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WARNING LETTER

December 12, 2022

WL 643578 

Dear Mr. Dinerman:

The United States Food and Drug Administration (FDA) inspected your ambient, refrigerated, and frozen warehouse facility, located at 2000 McKinnon Ave., Bldg. 427, Unit 12, San Francisco, CA 94124, from September 05-15, 2022. During the inspection, FDA investigators found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (CFR), Part 123 (21 CFR Part 123), and the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule) (21 CFR Part 117). At the conclusion of the inspection, the FDA investigators issued a Form FDA 483, Inspectional Observations, listing the deviations found at your firm. In addition, FDA investigators collected filth samples from various areas within your warehouse facility. FDA laboratory analyses of the samples found the presence of rodent and insect activity throughout your facility.

In accordance with 21 CFR § 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products 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). Based on our inspectional findings and analytical results, we have determined that the food products stored at your facility, including the ready-to-eat, refrigerated, reduced oxygen packaging Herring Fillets in Oil, are adulterated within the meaning of section 402(a)(4) of the Act in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. You may find the Act, the seafood HACCP regulation, the 4th edition of the Fish and Fisheries Products Hazards & Controls Guidance, 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 you a Form FDA 483, Inspectional Observations. You have not submitted a response to address these violations. Based on our review of the inspectional findings, we are issuing this letter to advise you of FDA’s continuing concerns and to provide detailed information describing the findings at your facility.

Seafood HACCP

1. You must implement the monitoring procedures that you have listed in your HACCP plan, to comply with 21 CFR § 123.6 (b). However, your firm did not implement the following monitoring procedures as listed in your HACCP plan for Herring Fillets in Oil.

a) You did not visually check the data generated by a temperature recording device during transit at your receiving critical control point (CCP) to control the listed hazards of C. botulinum toxin and histamine formation.

Specifically, on August 29, 2022, you received the following Herring Fillets in Oil products:

(b)(4)

Upon receipt of these reduced oxygen packaging (ROP), ready-to-eat (RTE) products, you did not review any transportation records as required by your HACCP plan. You explained to the investigator that your standard practice is (b)(4) to obtain a temperature upon receipt and record the temperature on your receiving log. This procedure is not what your plan requires, it is not adequate to ensure that proper temperatures were maintained during transit, and it is a repeat violation from your FDA inspection that ended on December 6, 2017.

b) You did not check a continuous temperature recording for your cooler (b)(4) as required by your HACCP plan at your refrigerated storage CCP with a critical limit of “Cooler temperature of (b)(4)” to control for the listed hazards of pathogenic bacteria growth and toxin formation, C. botulinum toxin formation, and histamine formation. Specifically, your cooler does not have a continuous temperature monitoring device. Additionally, you stated to the investigator that your standard practice is to (b)(4). This procedure is not what your plan requires and is not adequate to ensure that a proper temperature is maintained in the cooler.

Regarding the inadequacy of your monitoring, on September 7, 2022, our investigators used a calibrated traceable thermometer to take the following temperature readings from the cooler where you stored all your refrigerated seafood products, including ROP, RTE Herring Fillet in Oil:

• At 8:15 AM, the cooler temperature readout was 46.9°F
• At 1:30 PM, the cooler temperature readout was 54.6°F
• At 3:10 PM, the cooler temperature readout was 58.4°F

Furthermore, you did not have documentation showing that the thermometers you use have been calibrated for accuracy to comply with 21 CFR § 123.8 (a)(2)(ii) for the calibration of process-monitoring instruments. These are repeat violations from your FDA inspection that ended on December 6, 2017. We note that during the inspection you moved all your seafood products from the cooler to the freezer. Further, you stated that all seafood products will be stored in the freezer until you are able to install a continuous monitoring system for the cooler.

2. Because you chose to include a corrective action plan in your HACCP plan your described corrective actions must be appropriate to comply with 21 CFR § 123.7 (b). However, your corrective action plan for your Herring Fillets in Oil listed hazards of pathogenic bacteria growth and toxin formation, C. botulinum toxin formation, and histamine formation at the Receiving and Refrigerated Storage CCPs is not appropriate. Your corrective actions fail to ensure the cause of the deviation is corrected, such as discontinuing the use of the supplier until transit practices have improved and adjusting or repairing the cooler.

Your response to this warning letter should include the disposition of the product affected by the temperature deviation during refrigerated storage, and a revised HACCP plan along with at least five production days of CCP monitoring records to demonstrate implementation.

Sanitation

1. You must monitor the conditions and practices during processing with sufficient frequency to ensure conformance with the current good manufacturing practice requirements in 21 CFR Part 117, Subpart B (CGMPs), that are both appropriate to your plant and the food being processed and relate to one of the areas specified in 21 CFR § 123.11(b)(1)-(8), to comply with 21 CFR § 123.11 (b). However, your firm did not monitor for the presence of pests in the food plant with sufficient frequency to ensure that pests are not allowed in any area, as required by 21 CFR § 117.35(C). This is related to the exclusion of pests from the food plant, 21 CFR § 123.11 (b)(8). Specifically, on September 7 and 8, 2022, our investigators observed the following in your ambient food storage area:

a) There were many large, rat apparent rodent excreta pellets (AREPs) found along the entire perimeter (approximately 15 locations with 10 - 50 AREPs at each location) of your approximately (b)(4) ambient storage area in the back of your facility.
b) There were rat AREPs along approximately 25% of the perimeter wall in the approximately (b)(4) middle area of the facility.
c) There was a pallet of canned fish in jars with a cardboard box with seven jars of the canned fish also containing two apparent dead rats, cardboard nesting material, approximately 5 rat AREPs, an approximately 3" x 1" piece of pastry, possibly gingerbread, and five approximately 1" x 1" pieces of heart-shaped chocolates.
d) There were approximately ten locations with holes chewed through cardboard and chewed cardboard on pallets containing food products such as buckwheat, rice, pasta, and jars of mushrooms.
e) There was a large mass of shredded plastic, possibly nesting material, with a very strong smell of urine surrounded by approximately fifty large, rat AREPs, found behind a pallet of boxes of buckwheat.
f) There was a pallet of jars of pickled tomatoes with a box containing an apparent dead rat, approximately 20 rat AREPs, and apparent nesting material.
g) An apparent rodent gnaw hole was found on a bag of cavatappi pasta with manufacture date of 10/14/21 inside a case on a pallet of pasta.
h) There was a strong smell of urine in the eastern side of the middle part of the facility.
i) In the front part of the facility there was a pallet containing 3 cases of Tula Gingerbread with Cranberry Filling with manufacturing date 04/16/22. One case of the gingerbread had five apparently chewed packages, each also containing chewed product.

The presence of pests in a food facility can result in illness to consumers through microbial contamination. Rodents are known sources of Salmonella and parasites that can cause foodborne illness. This is a repeat violation from the FDA inspection that ended on November 19, 2014, when FDA investigators observed apparent rodent excreta pellets and an apparent rat running across pallets of food product in the firm’s ambient temperature warehouse.

Samples

Additionally, during the inspection, on September 8, 2022, FDA investigators collected samples for filth analysis by FDA laboratories and found the following violative results that support the above listed observations of rodent activities in your food storage areas.

• Sample 1189839 consisting of apparent rodent excreta pellets and nesting material was examined and found to contain rat excreta pellets, rat hairs, double incisor chew marks, live mites, dead insects, and urea.
• Sample 1189840 consisting of an apparent gnawed bag of Cavatappi pasta was examined and found to have at least 6 double incisor marks.
• Sample 1189841 consisting of an apparent gnawed bag of Tula gingerbread filled with fruit and berry filling was examined and found to have rodent double incisor marks.

Your response to this warning letter should include your corrective actions to clean these areas, exclude pests, your new frequency and procedure for sanitation monitoring for the exclusion of pests along with sanitation monitoring records for at least five production days to demonstrate implementation. For assistance with complying with 21 CFR § 123.11, you may consult the “Sanitation Control Procedures for Processing Fish and Fishery Products” document created by the Seafood HACCP Alliance available online at the following website http://ifasbooks.ifas.ufl.edu/p-99-sanitation-control-procedures-for-processing-fish-and-fishery-products.aspx.

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 that your firm complies with all requirements of federal law, including FDA regulations. You should take prompt action to address the violations noted in this letter. Failure to promptly address these violations may result in legal action without further notice, including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.

In addition to the above violations, we offer the following comment. To comply with 21 CFR § 123.10, you must have an individual who has successfully completed training in the application of HACCP principles to fish and fishery product processing that is at least equivalent to that received under a standardized curriculum recognized as adequate by the FDA or who may otherwise be qualified through job experience to perform the following functions: (1) the development of the HACCP plan, as required by 21 CFR § 123.6(b); (2) the reassessment and modification of the HACCP plan in accordance with the corrective action procedures specified in 21 CFR § 123.7(c)(5); (3) the reassessment and modification of the HACCP plan in accordance with the verification activities specified in 21 CFR § 123.8(a)(1);(4) the reassessment and modification of the hazard analysis in accordance with the verification activities specified in 21 CFR § 123.8(c); and (5) perform the record review required by 21 CFR § 123.8(a)(3). During the inspection you stated no one associated with your firm has completed seafood HACCP training. Further, based on the seafood HACCP violations described in this letter, it does not appear that any individual at your firm has sufficient seafood HACCP knowledge through job experience. You can view information on training and course availability from the Association of Food and Drug Officials (AFDO) at the following website https://www.afdo.org/training/sha/seafood-haccp/.

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 643578, 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
District Director | FDA San Francisco District
Program Division Director
Office of Human and Animal Food Operations West - Division 5