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April 4, 2024

WARNING LETTER
CMS #663221

Dear Ms. Gutierrez:

The U.S. Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) soft wheat flour tortilla manufacturing facility located at 6016 E. Vernor Hwy., Detroit, MI 48209 from April 3 through April 21, 2023. During our inspection, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, part 117 (21 CFR part 117).

Based on FDA’s inspectional findings, we have determined that the RTE soft flour tortillas manufactured in your facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)] in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)]. In addition, the “SOY FREE” label claim is false or misleading, which causes your tortilla products that are labeled as such to be misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)]. You may find the Act and further information about the CGMP & PC rule through links in FDA's home page at www.fda.gov.

At the conclusion of the inspection, FDA investigators issued an FDA Form 483 (FDA-483), Inspectional Observations. You provided responses to the inspection on May 5, 2023 and June 7, 2023, describing corrective actions taken or planned by your firm. After reviewing the inspectional findings and the responses that your firm provided, we are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility. We address your responses below.

Hazard Analysis and Risk-Based Preventive Controls (21 CFR 117, Subpart C):

1. Your hazard analysis for RTE soft flour tortillas did not identify and evaluate all known or reasonably foreseeable hazards to determine whether there are any hazards requiring a preventive control, as required by 21 CFR 117.130(a).

A. You did not identify and evaluate recontamination with environmental pathogens, such as Salmonella, to determine whether it is a hazard requiring a preventive control in your RTE soft flour tortillas, as required by 21 CFR 117.130(a)(1). Specifically, your firm’s written hazard analysis did not consider the hazard of recontamination with environmental pathogens at the “(b)(4)” and “(b)(4) steps. In addition, although your hazard analysis considered this hazard at the “(b)(4)” step, it determined that a preventive control was not necessary due to “SOP in place for personnel hygiene and SOP facility sanitization.” Your RTE tortillas are exposed to the environment prior to packaging where they could be contaminated with environmental pathogens such as Salmonella and do not receive a lethal treatment or otherwise include a control measure (such as formulation lethal to the pathogen) that would significantly minimize pathogens. Therefore, contamination with environmental pathogens is a known or reasonably foreseeable hazard, and a knowledgeable person manufacturing/processing food in your circumstances would identify recontamination with environmental pathogens as a hazard requiring a preventive control (i.e., sanitation controls). Sanitation preventive controls include procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens (see 21 CFR 117.135(c)(3)).

Your firm’s food safety plan, under the heading “Cleaning and Sanitizing Procedure” in the “Sanitation Preventive Controls” section, provides a general description of your facility’s cleaning and sanitation program components. These components do not identify any specific production equipment. The “Procedure” component references “Pre-op forms in process,” which was described by your Food Safety Assistant as the electronic spreadsheet titled “Cleaning and Sanitation Record” that your firm uses to document sanitation monitoring. However, this spreadsheet does not contain any written sanitation procedures or corrective action procedures.

In addition, sanitation preventive controls are subject to preventive control management components including monitoring, corrective actions, and verification as appropriate to ensure effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility’s food safety system (see 21 CFR 117.140).

We note that your food safety plan and related procedures do not include adequate corrective action procedures that include steps to identify and correct the problem, reduce the likelihood the problem will recur, evaluation of all affected food for safety, and preventing all affected food from entering commerce if you cannot ensure food is not adulterated (see 21 CFR 117.150(a)(2)).

Further, an environmental monitoring program is a required sanitation verification activity for your RTE soft flour tortillas, as they are exposed to the environment prior to packaging (see 21 CFR 117.165(a)). Your food safety plan, under the heading “Environmental Monitoring for Sanitation Control Verification,” includes references to a document titled “Microbial Control/Environmental Policy.” When asked by our investigators, your firm was unable to provide the “Microbial Control/Environmental Policy” and further stated that this policy was not implemented. Our investigators also noted that your facility only performs environmental sampling (b)(4) and only for Enterobacteriaceae (Eb). Eb is not a pathogen, and it is not an adequate indicator organism for the pathogen, Salmonella. As such, your firm’s environmental monitoring program is not verifying the effectiveness of your sanitation controls for Salmonella or other environmental pathogens.

In your responses, you identified a root cause of “SOP’s were not printed and readily available” and you included nine undated written procedures for cleaning and sanitizing equipment. In addition, your responses identified a corrective action indicating that you would revise your food safety plan and retrain personnel. However, the version of the food safety plan included in your responses is the same as the version provided to our investigators during the inspection and, as such, it appears you have not reanalyzed your plan or made modifications that are necessary to correct this observation. Furthermore, your responses do not include employee retraining records. We will verify the implementation and adequacy of your corrective actions during the next FDA inspection.

B. You did not identify and evaluate mycotoxins as a known or reasonably foreseeable hazard to determine whether they require a preventive control. Your facility manufactures RTE soft flour tortillas that contain wheat flour, which is an ingredient associated with mycotoxins such as deoxynivalenol (a.k.a. vomitoxin). A knowledgeable person manufacturing/processing food in your circumstances would identify mycotoxins as a hazard requiring a preventive control in this ingredient. A facility that identifies raw materials and other ingredients that require a supply-chain-applied control, such as vomitoxin in wheat flour, must establish and implement a risk-based supply-chain program for those raw materials and ingredients (see 21 CFR 117.405(a)(1)).

Your food safety plan has a section titled “Supply-chain applied Preventive Control Program,” which lists flour as having potential hazards of “Foreign Materials & Microorganisms,” but it does not specify vomitoxin or mycotoxins. This section lists a “verification method” of “Certificate of Analysis with (b)(4)”; however, our investigators noted that a certificate of analysis (CoA) your firm received from your wheat flour supplier did not include any vomitoxin testing results. Your firm also provided a letter from your wheat flour supplier titled, “FSMA VOMITOXIN REQUIREMENTS,” dated January 6, 2022, which describes your supplier’s frequency of testing grain ((b)(4)), frequency of testing finished product ((b)(4)), vomitoxin testing method, and corrective actions. However, there is no vomitoxin testing data included in the letter, and your firm did not have CoAs indicating your wheat flour supplier has conducted vomitoxin testing on any shipments of flour your firm has received.

In your responses you identified the root cause as “Vendors had not been providing with Analysis Report being made on the flour.” You also identified a corrective action as “Have requested latest reports of Analysis for Vomitoxin being tested on the flour and will receive tests going forward.” In addition, you included the aforementioned January 6 letter from your wheat flour supplier. It is unclear if your firm has “requested latest reports of Analysis for Vomitoxin being tested on the flour” from your wheat flour supplier, as there are no examples of such reports included in your responses.

As previously mentioned, the version of the food safety plan included in your responses is the same as the version provided to our investigators during the inspection and, as such, it appears you have not reanalyzed your food safety plan or made modifications that are necessary to correct this observation. We will verify the implementation and adequacy of your corrective actions during the next FDA inspection.

C. You did not appropriately identify and evaluate the hazard of “Survival of microorganisms due to low temperature” to determine whether it is a hazard requiring a preventive control for your RTE soft flour tortillas, as required by 21 CFR 117.130(a)(1).

Your firm’s hazard analysis considered the hazard of “Survival of microorganisms due to (b)(4)” at the “Baking” step but did not identify it as a hazard requiring a preventive control. Your firm manufactures RTE soft flour tortillas made from wheat flour. Wheat has been associated with vegetative bacterial pathogens such as pathogenic Escherichia coli (E. coli) and Salmonella. A knowledgeable person manufacturing/processing food in your circumstances would identify bacterial pathogen survival of a lethal treatment as a known or reasonably foreseeable hazard that requires a preventive control (i.e., process controls). Process preventive controls include procedures, practices, and processes to ensure control of parameters during operations such as baking. Process controls must also include the parameters associated with the control of the hazard and the maximum or minimum values needed to significantly control the hazards (see 21 CFR 117.135(c)(1)).

Your firm’s hazard analysis includes a written justification for not considering the hazard of “Survival of microorganisms due to (b)(4) temperature” at the “Baking” step of “Kill step will eliminate pathogens” and further states, “SOP’s in place for Temperature requirements for Quality and Safety.” However, your food safety plan does not include written baking procedures or established parameters for baking time and/or temperature. Your firm’s Food Safety Assistant informed our investigators that your firm does not have a documented established critical limit for baking time and temperature or any validation for the adequacy of the baking process. In addition, your firm’s employees informed our investigators that the “SOP’s in place for Temperature requirements for Quality and Safety” had not been created and could not be provided. Preventive controls are subject to preventive control management components (monitoring, verification, and corrective actions) as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system (see 21 CFR 117.140). You must also validate that the preventive controls are adequate to control the hazard as appropriate to the nature of the preventive control and its role in the facility’s food safety system (see 21 CFR 117.160).

Furthermore, you do not have controls in place to address the hazard of survival of bacterial pathogens such as Salmonella and E. coli in the baking process. While our investigators observed production of RTE soft flour tortillas, they noted that the digital temperature display for the oven did not appear to be functioning. Your firm management confirmed that it was not functioning, and it could not provide a temperature readout. Your firm’s Production Manager indicated that the digital temperature display has not functioned at any point while he had worked at your firm, which is approximately 20 years. Our investigators noted that your firm manufactures RTE soft flour tortillas of varying size with the following raw dough weights: 5” & 6” tortillas - 1.2 oz. raw dough, 8” tortillas - 1.7 oz. raw dough, 10” tortillas - 2.5 oz. raw dough, and 12” tortillas - 4.0 oz. raw dough. Your firm’s Production Manager stated that your firm does not change the oven belt speed at the baking step for any of the different tortilla types or sizes.

On April 17, 2023, during the production of RTE 8” whole wheat flour tortillas, the hot tortilla press malfunctioned resulting in unpressed balls of raw dough proceeding through the oven, onto the RTE tortilla (b)(4) cooling conveyor, and then onto the RTE tortilla conveyor belt that leads to the RTE tortilla counter/stacker. After exiting the oven, the unpressed balls of raw dough did not appear to be fully cooked. This process continued for approximately 10 minutes before your firm shut the line down for repairs. Neither the RTE tortilla (b)(4) cooling conveyor nor the RTE tortilla conveyor belt were re-cleaned or re-sanitized while the line was running when the first balls of unpressed dough were discovered.

Your firm provided written sanitation standard operating procedures (SSOPs) to our investigators via email, on April 11, 2023. The SSOPs denote a (b)(4) cleaning and sanitizing frequency for the “White transporter counter Stacker” and a (b)(4) cleaning and sanitizing frequency for the “Tortilla Stacker Rings,” “Tortilla Counter,” and “Cooling Conveyor.” Your RTE tortillas are exposed to the environment and come into direct contact with each of the above-mentioned pieces of equipment prior to packaging. Our investigators noted that these primary food contact pieces of equipment in the RTE area of the production line (cooling conveyor, and tortilla stacker/counter) are not disassembled for cleaning (see 21 CFR 117.135(a)(1)).

In your responses to the temperature at baking, you identified a root cause of “Monitoring controls for verification of temperature checks has not been implemented in the process” and identified corrective actions as “Production Batching logs were updated and retraining was implemented to Monitor and Verify Temperature checks. Verification of Product Temperature after Kill Step (baking) will be conducted to ensure Process is within temperature threshold for food safety.” In addition, you included a blank “FLOUR TORTILLA DAILY PRODUCTION LOG” that has been updated to include an area in which to record oven temperatures under the column heading “PH/Oven Temp °F.” However, your firm’s updated production log does not include an area to record baking time, so it is unclear if your firm plans to monitor and record baking time, and if so, how. Additionally, you did not include records of employee retraining or completed examples of your firm’s updated production log as evidence to show your firm has retrained your employees and is now recording the oven temperature during production.

In your responses, you also included a document explaining that (b)(4) has added a baking process kill step calculator for flour tortillas to its portfolio of validation services and included another document titled “BAKING PROCESS KILL STEP CALCULATOR: 100% whole wheat multigrain bread.” This baking process kill step calculator appears to be intended for use for whole wheat bread, not for the soft flour tortillas manufactured by your firm.

Your responses do not include an implementation date of your “…Verification of Product Temperature after Kill Step (baking) …to ensure Process is within temperature threshold for food safety” or provide an explanation as to how your firm will perform this procedure. Your responses also do not include any information or documentation explaining what actions, if any, your firm has taken or plans to take to address the non-functioning temperature display on the oven.

Finally, as previously mentioned, the version of the food safety plan included in your responses is the same as the version provided to our investigators during the inspection and, as such, it appears you have not reanalyzed your plan or made modifications that are necessary to correct this observation. We will verify the implementation and adequacy of your corrective actions during the next FDA inspection.

2. You did not identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility, as required by 21 CFR 117.135(a)(1). Specifically, you did not identify and implement an allergen preventive control for allergen labeling. Your food safety plan has a section for “Food Allergen Preventive Controls,” and this section identifies the “Product” as “All Flour Tortillas,” the “Allergen Statement” as “Contains Wheat,” and the “Label Number” as “Label Control under labeling program.” Your Food Safety Assistant stated that you do not verify that the allergen statement “Contains Wheat” is on the finished product label. They stated that the labels are verified for correct allergen statements only when they are received. Our investigators requested how this information was documented and were provided with the “AP[P]ROVED LABEL” document. Your firm’s Food Safety Assistant stated that there were no completed copies of this document and that use of this document has not been implemented. In addition, your food safety plan does not include the required preventive control management components such as monitoring, corrective action, or verification procedures or records. According to your food safety plan, all flour tortillas manufactured at your facility contain wheat, a known allergen. Therefore, your firm is not adequately controlling the hazard of undeclared allergens.

In your responses you identified the root cause as “Lack of adequate training of employees” and identified a corrective action of “Policy and Procedures were implemented, and employees have been trained, Re-fresher training will be conducted on (b)(4) basis and new hires will be trained as well.” In addition, you included your firm’s SOP titled “LABELING PROGRAM” Version 2 revised/reviewed in August 2019. However, your responses do not include employee training records or records demonstrating that your firm has implemented your “Policy and Procedures.”

As previously mentioned, the version of the food safety plan included in your responses is the same as the version provided to our investigators during the inspection and, as such, it appears you have not reanalyzed your plan or made modifications that are necessary to correct this observation. We will verify the implementation and adequacy of your corrective actions during the next FDA inspection.

21 CFR 117 Subpart B – Current Good Manufacturing Practice

1. You did not clean and sanitize your utensils or equipment in a manner that protects against contamination of food-contact surfaces, as required by 21 CFR 117.35(a). Specifically,

a. During cleaning operations at the end of the day on April 3, 2023, one of your firm’s employees used a high pressure hose to spray the floor of the raw production area resulting in water pooling over top of a floor drain and overspray contacting raw dough production equipment and empty mesh baskets that your firm uses to hold raw dough balls.

b. On the morning of April 11, 2023, during sanitization of the RTE tortilla (b)(4) cooling conveyor prior to the start of production, an employee used a hand-held spray bottle that produced a single stream of sanitizer which did not uniformly apply sanitizer on all food contact surfaces. After completion of sanitization and prior to the start of production, apparent residue and food particles were observed adhering to the food contact surface of the RTE tortilla (b)(4) cooling conveyor. Your firm used this equipment in this condition for RTE tortilla production.

c. On April 11, 2023, after completion of sanitization of tortilla production equipment and prior to the start of production, the following was observed on non-food contact surfaces of the RTE tortilla counter/stacker directly below the bungee bands (food contact surface) that convey stacks of unpackaged RTE tortillas: blackened residue on the inside edges of the plastic that houses piping that lowers tortillas, food particles and residues on the joint between the white plastic and adjoining stainless steel, and food particles and residues in the screw holes holding the plastic to the equipment.

In your responses you did not address these observations, so it is unclear what corrective actions, if any, you have taken or plan to take. We will verify the implementation and adequacy of any corrective actions during the next FDA inspection.

2. You did not maintain buildings, fixtures, and other physical facilities in your plant in a clean and sanitary condition and in repair adequate to prevent food from becoming adulterated, as required by 21 CFR 117.35(a). Specifically:

a. On April 3 and/or 6, 2023, our investigators observed broken concrete around the following four floor drains:

  1. Floor drain located in the raw production area near the 3-compartment sink that had grey/cloudy standing water on it that did not appear to drain during the duration of the production day;
  2. Floor drain located in the raw production area approximately 6’ away from the raw dough ball cutter;
  3. Floor drain located in the raw production area approximately 7’ away from the hot tortilla press; and
  4. Floor drain located in the RTE production area approximately 6’ away from the RTE tortilla (b)(4) cooling conveyor.

According to your firm’s Production Manager and Supervisor, the floor drain observed with grey/cloudy standing water on it had been in this condition for approximately one week. Our investigators also observed your firm’s employees walking back and forth over the floors where the above-mentioned floor drains are located and between the raw and RTE production areas of your facility.

b. On April 6, 2023, our investigators observed debris buildup on three panels hanging directly above the RTE tortilla (b)(4) cooling conveyor where RTE tortillas exit the oven.

c. On April 6, 11, and 17, 2023, our investigators observed chipping paint that is similar in color to raw tortilla dough and finished RTE tortillas on the following metal production equipment:

1. Food contact surface of the dough hopper where raw tortilla dough exits the hopper,
2. Non-food contact surface of the interior walls of the dough hopper surrounding the conveyor transporting raw tortilla dough into the dough ball cutting machine,
3. Non-food contact surface of the interior of the dough cutter,
4. Non-food contact surface of the side rails of the RTE tortilla (b)(4) cooling conveyor, and
5. Non-food contact surfaces adjacent to each side of the RTE tortilla conveyor belt.

d. On April 6, 11, and 17, 2023, our investigators observed raw dough on the floor in the raw production area next to the dough cutter and mesh baskets that are used for transporting raw tortilla dough balls. Our investigators also observed your firm’s employees passing from the RTE production area through this raw production area and then back to the RTE production area without changing or cleaning their shoes when crossing over from the raw production area to the RTE production area. On April 11, 2023, prior to the start of production, our investigator observed a piece of raw dough on the floor with live ants on it in the RTE production area near the exit of the oven and next to the RTE tortilla (b)(4) cooling conveyor.

In your responses to the damaged floor drains you identified the root cause as “Drains broke due to the age of building.” You also identified a corrective action of “Drains have been currently repaired to a working condition, more in deep repairs are needed to prevent future problems. Will continue to monitor condition of drains and will ensure to block areas with cones and employee signs if at any case there is a break to prevent contamination due to employee traffic.” However, your responses do not include any evidence showing that the floor drains have been repaired. In addition, it is unclear when your firm plans to begin monitoring the condition of the floor drains, how frequently monitoring will be done, how the monitoring will be documented, and who will perform the monitoring.

In your responses to the debris on the panels you identified a root cause of “Panels were installed and no SOP’s for cleaning were created or added to the Master Cleaning Schedule.” You also identified a corrective action of “SOP’s were created for cleaning this structure and panels were added to the master cleaning schedules, pictures attached show panels cleaned (file attached).” However, your responses do not include any documentation to show that your firm created SOPs for cleaning this structure and panels or added them to your Master Cleaning Schedule. In addition, your responses included two photos that appear to be the hanging panels. However, both photos are close-ups, so it is unclear exactly where in your firm’s facility the photographs were taken.

In your responses to the chipping paint you identified a root cause of “Strategies to prevent Hazard due to peeling paint were not implemented due [to] not including Issue in the Master Maintenance Program.” You also identified a corrective action of “Visual Inspections of equipment will include chipping paint of equipment and facilities have to be included in the Master Maintenance Program, Plan Maintenance will have to strategize Project Task to correct findings this will include Project to be completed, time line and financial resources needed.” However, your responses do not include an explanation as to what specific corrective actions, if any, your firm has taken or plans to take to address the chipping paint on the equipment referenced in this observation, nor do they include evidence demonstrating your firm has taken corrective actions. In addition, it is unclear when your firm plans to add visual inspections of equipment and facilities for chipping paint to your Master Maintenance Program and begin conducting such inspections.

In your responses for employees not taking proper precautions when moving from the raw production area to the RTE production are you identified a root cause of “Lack of adequate training for daily maintenance of the Plant on the Daily Operations.” You also identified a corrective action of “Employees were re-train[ed] for Maintenance of Facility through the day on daily operation, and traffic control will be implemented to segregate Raw Area from Cooked Areas to mitigate employee traffic.” However, your responses do not include information regarding the retraining of your employees such as retraining dates or records. In addition, your responses do not include an explanation as to when your firm plans to implement an employee traffic program or what this program will consist of. We will verify the implementation and adequacy of your corrective actions during the next FDA inspection.

3. You did not take effective measures to exclude pests from your food plant to protect against contamination of food, as required by 21 CFR 117.35(c). Specifically, on April 11, 2023 during sanitization and manufacturing operations for 12” flour tortillas with Julian date code 23100 Best by 5/25/23, our investigators observed 10-15 live apparent cockroaches in various areas of your facility, including the RTE tortilla packaging area, near the RTE tortilla (b)(4) cooling conveyor, near the 3-compartment sink, and next to unused finished product boxes.

In your responses you identified a root cause of “Drains were not screened to prevent bugs from coming t[h]rough.” You also identified a corrective action of “Drains are in the process of being screened to prevent any bugs from coming through and pesticides have been applied to prevent infestation through the Contracted Pest Control company.” However, your responses do not explain which of your firm’s floor drains, if any, have been screened, nor do they include evidence showing that your firm has screened any floor drains. In addition, your responses do not include an estimated timeframe or date when your firm plans to complete the process of screening drains, nor do they specify a date when pesticides were applied or include records of their application.
We will verify the implementation and adequacy of your corrective actions during the next FDA inspection.

Misbranding

1. Your 313 Urban Tortillas brand Street Taco Flour Tortillas, Taco & Fajita Flour Tortillas, and Wraps products are misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)] in that the labels are false or misleading. Specifically, your 313 Urban Tortillas brand products declare “Soy Free” on the principal display panels; however, the tortillas are fabricated, in part, using a soy-based shortening comprised of soybean oil and hydrogenated soybean oil, both of which are declared in the ingredient statements on the product labels. Therefore, the “Soy Free” claim on the product labels is false or misleading.

2. Your 313 Urban Tortillas brand Street Taco Flour Tortillas, Taco & Fajita Flour Tortillas, and Wraps products are misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. 343(q)] because the Nutrition Facts labels do not meet the requirements in 21 CFR 101.9(c). Specifically, the labels bear the nutrient content claims, “CHOLESTEROL FREE” and “ZERO TRANS FAT” but the Nutrition Facts labels do not include declarations for polyunsaturated fat and monosaturated fat, as required by 21 CFR 101.9(c)(2)(iii) and (iv), when a claim is made about fatty acids or cholesterol.

During the inspectional closeout meeting on April 21, 2023, your firm’s Food Safety Assistant stated that your firm would remove the “SOY FREE” claim from the label. However, your responses to the inspection do not address this, nor do they include documentation showing your firm has made updates to this product label. We will verify the implementation and adequacy of your corrective actions during the next FDA inspection.

The violations cited in this letter are not intended to be an all‐inclusive list of violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our findings and provides you an opportunity to address them. You should take prompt action to correct any violations. Failure to adequately address this matter may lead to legal or regulatory action, including, without limitation, seizure and injunction.

Please notify FDA in writing, within fifteen (15) working days from your receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of any documentation and information that would assist us in evaluating your corrections and plans to prevent recurrences. If you cannot complete corrective actions within fifteen (15) working days, state the reason for the delay and the timeframe within which you will complete the correction. If you believe you have complied with the Act and FDA regulations, include your reasoning and any supporting information for our consideration.

Please send your written response to Darren S. Morgan, Compliance Officer, at ORAHAFEAST6FirmResponses@fda.hhs.gov. Alternatively, you may mail your response to Darren S. Morgan, 300 River Place Dr., Suite 5900, Detroit, MI 48207. If you should have any questions regarding this letter, please contact Darren S. Morgan at (313) 393-8149.

Sincerely,
/S/

William R. Weissinger, MS
Program Division Director
Office of Human and Animal Foods Operations East
Division 6