WARNING LETTER

Gold Star Smoked Fish Corp. MARCS-CMS 532876 — December 15, 2017

Delivery Method:: UPS

Recipient:: Recipient Name

Mr. Robert Pincow; Gold Star Smoked Fish Corp.; 570 Smith Street
Brooklyn, NY 11231
United States

Issuing Office:: New York District Office; United States

WARNING LETTER
CMS # 532876

VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED

December 15, 2017

Mr. Robert Pincow, President
Gold Star Smoked Fish Corp.
570 Smith Street
Brooklyn, NY, 11231

Dear Mr. Pincow:

The United States Food and Drug Administration (FDA) inspected your facility located at 570 Smith Street, Brooklyn, NY, 11231 from April 26 through May 12, 2017. During our inspection, FDA collected environmental samples from various areas in your facility, including areas that are near food during processing operations and near your food contact surfaces. FDA laboratory analyses of the environmental samples (i.e., swabs) identified the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility. At the conclusion of the inspection, the investigator issued your facility an FDA Form-483, Inspectional Observations. Based on FDA’s analytical results for the environmental swabs coupled with observations made by our investigator during that inspection, we have determined that during that inspection you were processing your RTE cold and hot smoked seafood products under conditions that cause your RTE cold and hot smoked seafood products to be 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 the food had been prepared, packed or held under insanitary conditions whereby your fishery products may have been rendered injurious to health. You may find the Act and FDA's regulations through links in FDA's home page at http://www.fda.gov.

We acknowledge your firm’s response dated June 5, 2017, which included a description of corrective actions taken by your firm. The adequacy of your firm’s implementation of those corrections and your firm’s ability to effectively control the presence of the pathogen, Listeria monocytogenes in your facility will be assessed during our next inspection. You must implement an effective strategy for environmental control of Listeria monocytogenes within your processing and packing environment. FDA recognizes that effective controls against this organism can be challenging and it is your responsibility to effectively address this challenge to ensure the safety of your products. Consuming foods contaminated with L. monocytogenes can lead to a severe, sometimes life-threatening illness called listeriosis, which is a major public health concern due to the severity of the disease, its high case-fatality rate, its long incubation time and its tendency to affect individuals with underlying conditions.

FDA laboratory analysis of the environmental sample INV987101 collected at your facility on April 26, 2017, confirmed that fifteen (15) of one hundred ten (110) environmental swabs were positive for L. monocytogenes. Specifically, eleven (11) of the fifteen (15) positive swabs were taken from wheels of stainless steel carts (also referred to as tanks) used to thaw, brine and transport seafood products between the “(b)(4),” “(b)(4)” and “(b)(4).” These current environmental swab samples, coupled with the microbial results from the environmental sample INV930241 that FDA collected during our June 2016 inspection, indicate that your facility is not achieving satisfactory control against the presence of Listeria monocytogenes within your facility and implementing effective methods and controls to locate niche or harborage points of the organisms within the environment to eliminate and minimize exposure to food and food contact surface during production.

As you know, our testing from the June 2016 samples also revealed L. monocytogenes in twelve (12) out of one hundred eight (108) locations within your facility with six (6) of the positives from the wheels of various equipment including these carts also referred to as tanks. To demonstrate the significance of these findings in the context of your sanitation program, including your cleaning and sanitizing operations and your facility and equipment design, we advise you about our results on our Whole Genome Sequencing (WGS) testing and comparative analysis. We conducted WGS testing on the twelve (12) L. monocytogenes isolates obtained from the FDA environmental sample collected on June 21, 2016 and the fifteen (15) L. monocytogenes isolates obtained from the FDA environmental sample collected on April 26, 2017. At this time, the WGS phylogenetic analysis found that there are two (2) strains of L. monocytogenes present in your facility and both of these strains contain isolates that were found during both our 2016 and 2017 inspections as referenced above. This evidence demonstrates that L. monocytogenes has maintained its presence within your production facility since 2016. The reoccurring presence of an identical strain of L. monocytogenes in your environment indicates a resident strain or niche harborage site is present in your facility. In your situation, you have two such strains to eliminate and effectively control. These findings also demonstrate that your sanitation procedures are inadequate to control, reduce, or eliminate this pathogenic organism from your facility. Once established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product.

We acknowledge that your June 5, 2017, response outlines the corrective actions you have taken in response to the L. monocytogenes environmental sample findings. We acknowledge that you have cleaned and sanitized your processing environment, conducted environmental sampling, and that finished product was tested for L. monocytogenes. Your response also describes intensified environmental sampling being conducted after cleaning and sanitizing and before resuming production. At this time, we cannot verify the adequacy of the methods and controls you have used to identify the potential harborage sites for L. monocytogenes in your processing environment or that the methods and controls effectively prevent L. monocytogenes from contaminating finished products you may manufacture in the future. We will verify the adequacy of your corrective actions during any future inspection.

We encourage that you review FDA’s draft guidance for industry titled, “Control of Listeria monocytogenes in Ready-To-Eat Foods” for assistance in developing your Listeria control plan. The draft guidance can be found at:
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm073110.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

This letter is not intended to be an all-inclusive list of the violations that exist in your products and facility. It is your responsibility to ensure that your products and facility are in compliance with the Act and all applicable laws, including the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, [21 CFR Part 123].

You should take prompt action to remedy the food safety risk from what appears to be two resident environmental pathogen strains of Listeria monocytogenes existing within your food facility. Failure to do so may result in regulatory action without further notice, including without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.

Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.

You should respond in writing within fifteen working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct violations, including an explanation of how your firm plans to prevent the recurrence of the violations described above or the occurrence of similar violations. More specifically, your response should include documentation of the corrective actions your firm has taken. If your firm’s planned corrective actions will occur over time, please include a timetable for implementation of those activities. If corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Please include copies of any available documentation demonstrating corrections have been made.

Please send your reply to the Food and Drug Administration, Attention: W. Martin Rennells, Compliance Officer, One Winners Circle, Suite 110, Albany, NY 12205. If you have questions regarding any issues in this letter, please contact W. Martin Rennells at 518-453-2314 x1038.

Sincerely,
/S/

Ronald Pace
Program Division Director
Office of Human and Animal Food Operations -
East Division 1

Cc:
Mrs. Galina Pincow, Vice President
Gold Star Smoked Fish Corp.
570 Smith Street
Brooklyn, NY, 11231

Mr. Igor Pozumentshchikov, QC and Operations Manager
Gold Star Smoked Fish Corp.
570 Smith Street
Brooklyn, NY, 11231