Gold Star Smoked Fish Corp. FDA Warning (2017)

Detailed Analysis

False Claims and Regulatory Violations

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 list

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. W

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 c

Potential Health Risks

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 dete

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.

Regulatory Context

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

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 collecte

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