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WARNING LETTER

September 7, 2023

WL 658436

Dear Mr. Lee:

The United States Food and Drug Administration (FDA) inspected your food manufacturing facility, located at 2937 E Pico Blvd, Los Angeles, CA 90023 on February 16, 2023 through April 6, 2023. Your firm contract manufactured refrigerated ready-to eat (RTE) baby food products in reduced oxygen packaging (ROP). This inspection was initiated due to a consumer complaint which involved a case of infant botulism. During the inspection, the FDA investigator found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). At the conclusion of the inspection, FDA issued a Form FDA 483, Inspectional Observations, listing the deviations found at your firm.

Based on FDA’s inspectional findings and analytical results for finished product samples, we have determined that the RTE ROP baby food products 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)]. Further, we found significant violations of the labeling regulations for foods, 21 CFR Part 101. These violations cause your (b)(4) baby food products to be misbranded within the meaning of section 403 of the Act (21 U.S.C. § 343). You may find the Act and FDA’s regulations through links in FDA’s home page at http://www.fda.gov/.

On April 27, 2023, FDA received your written response, describing corrective actions taken and planned by your firm. After reviewing the inspectional findings and response 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 also address your response below.

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

1. Your hazard analysis did not identify and evaluate known or reasonably foreseeable hazards to determine whether there are any hazards requiring a preventive control for your refrigerated RTE ROP baby food, as required by 21 CFR § 117.130(a)(1). Specifically, your hazard analysis for (b)(4) RTE baby food did not identify and evaluate the following hazards to determine whether they require a preventive control:

a. You did not identify and evaluate bacterial growth and/or toxin formation due to reduced oxygen packaging (i.e., Clostridium botulinum (C. botulinum)) during storage of refrigerated RTE ROP baby food products. Your hazard analysis identifies pathogens including L. monocytogenes as a biological hazard requiring a preventive control at the Cold Storage step, but it does not specifically identify sporeforming C. botulinum growth and/or toxin formation due to reduced oxygen packaging. RTE baby food products (including (b)(4), and (b)(4)) are packaged and stored in ROP. Various ingredients in these products grow in the ground or are associated with soil, where spores of C. botulinum may be present. Therefore, bacterial growth and/or toxin formation due to reduced oxygen packaging (i.e., anaerobic C. botulinum) is a known or reasonably foreseeable hazard at the cold storage step. These products do not receive a treatment lethal to nonproteolytic or proteolytic C. botulinum before or after packaging, and their formulation does not control for the growth and/or toxin formation of C. botulinum. A knowledgeable person manufacturing/processing food in your circumstances would identify bacterial growth and/or toxin formation due to reduced oxygen packaging as a hazard requiring a preventive control. Process controls include procedures, practices, and processes to ensure the control of parameters during operations. Such controls could include formulation (e.g., decreasing pH or water activity), heat processing (e.g., a cook that targets nonproteolytic C. botulinum), or refrigeration (e.g., temperature control below (b)(4) with the use of time temperature indicators on each package). Process controls must include the parameters associated with the control of the hazard and the minimum and maximum values needed to significantly minimize or prevent the hazards (see 21 CFR § 117.135(c)(1)).

We note that you do not have adequate controls in place for bacterial growth and/or toxin formation due to reduced oxygen packaging, as evidenced by the following:

i. Your written Process Control (HACCP Plan) states, “Product temperature will not rise above (b)(4), In the event of a natural disaster, loss of power for an extended period of time, or air temperature above (b)(4) for any other reason, product temperatures will be monitored to ensure product temperature does not exceed (b)(4).” This maximum value for temperature is insufficient to control for the hazard of C. botulinum toxin formation in RTE sealed baby food in ROP. Nonproteolytic C. botulinum can grow at a minimum temperature of (b)(4); it can grow and produce a deadly toxin after two days when temperatures are between (b)(4)°F. During the inspection you indicated that sealed baby food products can remain in Cooler (b)(4) for up to (b)(4) until being transported off-site.

ii. On February 21, 2023, during the storage of RTE ROP (b)(4) baby food lot # (b)(4) and (b)(4) lot # (b)(4), our investigator measured the air temperature of Cooler (b)(4) at 5:58 a.m. using an FDA-issued calibrated thermometer, and the temperature was measured to be 46.0°F. At the same time, your firm’s thermometer read the air temperature to be approximately 39.0°F. You stated that the dial thermometer in Cooler (b)(4) is not calibrated. In addition, your Daily Cooler & Freezer Temperature Check monitoring record, dated February 21, 2023, used to document the air temperature of Cooler (b)(4), indicates the temperature measured by your firm exceeded (b)(4)F on several occasions. For example, this monitoring record identified the following air temperatures during storage on February 21,2023:

• 39.0°F at 10:10 a.m.
• 40.0°F at 2:12 p.m.
• 40.0°F at 4:12 p.m.
• 39.0°F at 10:15 a.m.

Furthermore, on February 16, 2023, during the storage of RTE ROP (b)(4) baby food lot # (b)(4), our investigator measured the air temperature of Cooler (b)(4) at 11:57 a.m. using an FDA issued calibrated thermometer, and the temperature was measured to be 42.4°F. In addition, the air temperature recorded for Cooler (b)(4) in your Daily Cooler & Freezer Temperature Check monitoring record, dated February 16, 2023, documented that the air temperature was 39.0°F at 12:40 p.m.

iii. On February 3, 2023, FDA collected Sample #1207380 of 12 – 4 fl oz (118 mL) unopened plastic jars of assorted (b)(4) flavors from the complainant involved in the infant botulism consumer complaint. Non-toxin forming Clostridium botulinum was detected in subsample 11, and Clostridium beijerinckii was detected in subsample 12. In addition, FDA’s inspection included the collection of finished product samples consisting of (b)(4) – approximately 4 fl oz subsamples of (b)(4) (b)(4) baby food (Sample #1189052) and (b)(4) - approximately 4 fl oz subsamples of (b)(4) (Sample #1189054), both collected on March 7, 2023, in which non-toxin forming C. botulinum was detected in subsamples 26 and 28, respectively.

b. You did not identify and evaluate recontamination with environmental pathogens (e.g., Listeria monocytogenes) at steps where your RTE baby food products are exposed to the environment. The cooked (steamed) RTE ingredients used for the RTE baby food products are exposed to the environment at post-cooking steps (including Cooling, Blending, and Filling) until the packages are sealed. The baby food products do not receive a lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogens) that would significantly minimize pathogens. Therefore, recontamination with environmental pathogens is a known or reasonably foreseeable hazard. Further, a knowledgeable person manufacturing/processing food in your circumstances would identify recontamination with environmental pathogens as a hazard requiring a preventive control. Sanitation 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 and biological hazards due to employee handling (see 21 CFR § 117.135(c)(3)). Note that environmental monitoring is required if contamination of an RTE food with an environmental pathogen is a hazard requiring a preventive control (see 21 CFR § 117.165(a)(3)).

In your response, you stated you purchased (b)(4) new temperature data monitors for Coolers (b)(4) and submitted the accompanying Certificates of Calibration. You stated “these will ensure monitoring visibility even when staff are not on site via mobile application. They have alarm settings to monitor set temperature parameters.” You also stated your QA staff will reference the data from the monitors “(b)(4) temperatures plus the use of calibrated handheld thermometers to ensure Cooler temperatures do not go over (b)(4)F while stored WIP and finished product is inside cooler (b)(4) and (b)(4).” However, you did not address how you will monitor the air temperature in Cooler (b)(4) or what the maximum temperature must be; Cooler (b)(4) was observed being used for the storage of RTE ROP baby food products during the inspection. You also did not indicate whether the dial thermometer in Cooler (b)(4) has been calibrated since the inspection.

Furthermore, you stated that you entered into a contract with a third-party lab to initiate environmental monitoring the first week of June 2023. The monitoring will include Zones (b)(4) and will become (b)(4) task conducted by your QA Department. Although you stated the “environmental program will ensure that our sanitation procedures are adequate to prevent the hazard of recontamination with environmental pathogen,” you did not submit a written environmental monitoring program.

Lastly, you stated you have not manufactured any products for (b)(4). dba (b)(4) since (b)(4), nor have you used their equipment, packaging, and raw inventory to make any other products. (b)(4). We note that your response did not address the specific violation by indicating whether you have reevaluated the hazard analyses associated with refrigerated RTE ROP baby food products manufactured at your facility.

2. You did not implement your written procedures for monitoring a preventive control, including the frequency with which they are to be performed, as required by 21 CFR § 117.145(a). Specifically, for “(b)(4) Food” including RTE pureed baby food products (made from fruits, vegetables, and grains such as (b)(4)), you have a preventive control at the Cooling step to control pathogen growth. You do not follow the requirements in your preventive control procedures and forms as evidenced by the following:

a. The critical limit in the preventive control procedure is listed as: “(b)(4)” for various pathogens including Bacillus cereus (B. cereus) and L. monocytogenes. However, when our investigator asked for the specific cooling parameters that were being followed in practice, you instead provided the United States Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) Appendix B to Compliance Guidelines, updated June 1999, entitled “Compliance Guidelines for Cooling Heat-Treated Meat and Poultry Products (Stabilization).” The latter document provides different cooling parameters than those listed in the FSPCA manual.

b. Your monitoring record for cooling states: “To avoid foodborne pathogen the following must be met: Time needs to be recorded when temperature has reached (b)(4)°F. Once at (b)(4)°F, product has (b)(4), product has (b)(4) to reach (b)(4)F.” However, your monitoring record for post-steaming cooling shows the following temperatures taken during the cooling of (b)(4), during the processing of (b)(4) baby food lot # (b)(4):

The following day, our investigator measured the internal temperature of the above-mentioned (b)(4), which was stored in a metal tray within Cooler (b)(4). On February 22, 2023, at (b)(4)., the temperature of the (b)(4) located around the center of the tray was measured to be (b)(4)F. You did not take corrective actions when the cooling temperature parameters were not met.

In addition, you do not monitor the internal temperature of the cooked (b)(4) to determine when it reaches a temperature of ≤ (b)(4)F. In practice, the temperature of the (b)(4) is monitored for up to (b)(4) from the start of cooling and is not measured again until the grinding step, which is typically conducted during production the following day.

c. The monitoring frequency in the preventive control procedure is listed as: “QA or trained designee will monitor time and temperature at minimum once per hour at the thickest part of the product.” However, you are not monitoring or recording the time and temperature during cooling (b)(4), as your monitoring record for cooling only shows temperatures recorded at the start of cooling, the time the product reaches (b)(4)F, after (b)(4), and (b)(4).

In your response you stated you have not manufactured any products for (b)(4) since March 3, 2023, nor have you used their equipment, packaging, and raw inventory to make any other products. You furthered indicated that all of their inventory and equipment is on collection hold and will be liquidated once you have the rights. We will verify you are no longer manufacturing (b)(4) products during the follow-up inspection.

Current Good Manufacturing Practice (21 CFR Part 117, Subpart B):

1. Your plant was not constructed in such a manner that floors, walls, and ceilings may be adequately cleaned and kept clean and in good repair; and that drip or condensate from fixtures, ducts and pipes does not contaminate food or food-contact surfaces, as required by 21 CFR § 117.20(b)(4). Specifically,

a. On February 16, 2023, while your firm was filling and sealing (b)(4) baby food lot # (b)(4), the investigator observed water dripping from the condenser unit in cooler (b)(4) where you fill jars of baby food, which created standing water on the floor. A (b)(4) containing trays of RTE uncovered jars of (b)(4) baby food was stored over the standing water. The bottom tray of product was approximately 7 inches from the floor and standing water.

b. During production on February 21, 2023, a green rolling container containing RTE steamed broccoli was stored next to wet floors with uneven surfaces/holes in the kitchen.

Your April 27, 2023 response stated that a “new (b)(4) was installed to eliminate the dripping by 3rd party contractor,” and you provided a photograph as evidence of corrective action. However, it’s unclear if the catch pan prevents droplets from splashing out of the catch pan and onto product or food contact surfaces. In addition, you submitted a copy of your purchase order/work order issued to a third-party for the repair of all uneven surfaces/holes containing water on the kitchen floor. You “estimate based on the contractor’s timeline that the work will be completed by 5/28/2023.” We will verify the adequacy and effectiveness of your firm’s corrective actions during the follow-up inspection.

Misbranding Violations:

Your (b)(4), and (b)(4) baby food products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. §343(q)] in that the product labels fail to declare any nutrition information required per section 21 CFR 101.9.

Your (b)(4) is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required by section 21 CFR 101.4. Specifically, the ingredients for the (b)(4) are not listed on the product label in descending order of predominance by weight, as required by section 101.4(a)(1). For example, according to your (b)(4) Recipe document, the (b)(4)) contains the following ingredients:

• (b)(4)
• (b)(4)
• (b)(4)
• (b)(4)
• (b)(4)

Your Bell Pepper Apple Bowl label fails to declare water as an ingredient. Based on the recipe, ice was used in make this product but it is not declared on the label. In accordance with CPG Sec 555.875 Water in Food Products (Ingredient or Adulterant), https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-555875-water-food-products-ingredient-or-adulterant, water must be declared as an ingredient unless all water added during processing is subsequently removed by baking or some other means during processing (section 21 CFR 101.100(a)).

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

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.

In addition to the violations described above, we offer the following comments:

• Your process control at the Cooking step in your HACCP plan for “(b)(4) Food” including pureed baby food lists a critical limit of “Produce will be cooked to a minimum of (b)(4)°F for (b)(4) seconds.” When the FDA investigator asked if you had a validation study or any other documentation to support the cook parameters of (b)(4)°F for (b)(4) seconds, you provided the USDA FSIS Appendix A to Compliance Guidelines, updated June 1999, entitled “Compliance Guidelines for Meeting Lethality Performance Standards For Certain Meat and Poultry Products.” This document does not provide validation for inactivation of Listeria monocytogenes at the identified parameters.
• The net quantity of contents for your (b)(4) RTE baby food products is not provided as a distinct item in the bottom 30 percent of the principal display panel (PDP) in accordance with section 21 CFR 101.7(f). If the PDP is five (5) square inches or less, the requirement for placement within the bottom 30 percent of the area of the label panel does not apply when the declaration of net quantity of contents meets the other requirements of section 21 CFR 101.7.
• The net quantity of contents for your (b)(4) RTE baby food products is not provided in terms of weight, but rather fluid measure (fl. oz/mL). The net quantity of contents must be expressed in the terms of weight if the food is solid, semisolid, or viscous, or a mixture of solid and liquid as required by section 21 CFR 101.7(a). These foods are purees of solid foods; therefore, the net quantity must be provided in terms of weight.
• Based on the instructions in your recipes, your (b)(4) and (b)(4) products may also be made with water which is not declared on the label as required by section 21 CFR 101.4(a).
• In accordance with section 21 CFR 101.13(b)(3), except for claims regarding vitamins and minerals described in section 21 CFR 101.13(q)(3), no nutrient content claims may be made on food intended specifically for use by infants and children less than 2 years of age unless the claim is specifically provided for in parts 101, 105, or 107. The product webpages state, “no added sugar” and either “Baby Food for 9 Month +” or “Baby Food for 6 Month +.” “No added sugar” is a nutrient content claim defined in section 21 CFR101.60(c)(2).

Please notify FDA in writing, within 15 working days of 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 related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Your written response should be sent electronically to: orahafwest5firmresponses@fda.hhs.gov.

Otherwise, a hardcopy response can be sent to:

Sergio Chavez, Director, Compliance Branch
Food and Drug Administration
Office of Human and Animal Food Operations West - Division 5
1201 Harbor Bay Parkway
Alameda, CA 94502

Refer to Unique Identification Number, CMS 658436, when replying. If you have questions regarding this letter, please contact Clarice J. Ahn, Compliance Officer at clarice.ahn@fda.hhs.gov, or 510-337-6854.

Sincerely,
/S/

Darla R. Bracy
Program Division Director
Office of Human and Animal Food Operations - West Division 5

Cc:
(b)(4)