Inspections, Compliance, Enforcement, and Criminal Investigations

Royal Seafood Baza 10/20/15

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
New York District 
158-15 Liberty Avenue
Jamaica, NY 11433             

 

October 20, 2015
 
WARNING LETTER NYK-2016-5
 
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
Mr. Edward Shnayder, CEO
Royal Seafood Baza, Inc.
175 Lake Avenue
Staten Island, NY 10303-2727
 
Dear Mr. Shnayder:
 
The United States Food and Drug Administration (FDA) inspected your seafood processing facility, Royal Seafood Baza, Inc., located at 175 Lake Avenue Staten Island, NY 10303-2727 on March 12, 2015 through March 19, 2015. During that inspection, FDA found that your facility had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part123) and the Current Good Manufacturing Practice (cGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). That inspection resulted in FDA’s issuance of an FDA-483, Inspectional Observations, listing the deviations found at your firm at the conclusion of the inspection. We acknowledge receipt of your response sent on April 18, 2015 and received on April 30, 2015. Your response included various documents, including revised HACCP plans and description of corrections to the observations of concern noted on the FDA-483.    
 
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). Additionally, as an importer of fish or fishery products, you must operate in accordance with the requirements of 21 CFR Part 123.12. In accordance with 21 CFR Part 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 123. This section states that if assurances do not exist that the imported fish or fishery products have been processed under conditions equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Act, [21 U.S.C. § 342(a)(4)]. Accordingly, your salt-cured herring fillets packed in salt brine, salt-cured herring fillets packed in oil or vacuum-packaged, and caviar productsare adulterated, in that they havebeen prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
 
Based on our review of your April 18, 2015 response, your significant violations are as follows:
 
1.    You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur to comply with 21 CFR Part 123.6 (a) and (c)(1). A food safety hazard is defined in 21 CFR Part 123.3 (f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." Your firm’s HACCP plan for “Receipt, Cold Storage, and Distribution of Caviar Products” does not list the food safety hazard of Clostridium botulinum growth and toxin formation at the “Labeling of Finished Product” critical control point. Additionally, we would like to note that your labels allow for the product to be thawed and stored under refrigeration for up to 2 weeks (i.e., “Keep Frozen. Thaw Under Refrigeration. Keep In Refrigerator 2 Weeks At 38°F Or Below”). FDA strongly recommends the use of time/temperature integrators must be incorporated into your process and HACCP plan or that the product either be labeled “Keep Frozen, Thaw under refrigeration immediately prior to use”. Alternatively, your firm may choose to control the hazard by establishing critical limits that achieve a water phase salt level of at least 5% or a water activity below 0.97.
 
2.    You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points to comply with 21 CFR Part 123.6 (a) and (c)(2). A critical control point is defined in 21 CFR Part 123.3 (b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." 
 
a.    Your firm’s HACCP plan for “Receipt, Cold Storage, and Distribution of Caviar Products” does not list the critical control point of refrigerated storage for controlling the food safety hazard of pathogen growth and toxin formation. According to your process flow chart after receiving the refrigerated product it is then placed in refrigerated cold storage. FDA recommends establishing a critical limit and monitoring procedures that measure the ambient temperature of the cooler continuously to ensure the product is held and stored at 40ºF or below.
 
b.    Your firm’s HACCP plan for “Receipt, Cold Storage, and Distribution of Caviar Products” does not list the critical control point of unrefrigerated processing controls for controlling the food safety hazard of pathogen growth and toxin formation. During the repackaging of your thawed caviar or refrigerated caviar the cumulative exposure time of product at unrefrigerated ambient temperatures (i.e. temperatures exceeding 4.4°C) should be monitored. FDA recommends establishing critical limits for safe exposure times based on exposure temperature.
 
3.    You must have a HACCP plan that, at a minimum, lists the critical limits that must be met to comply with 21 CFR Part 123.6(c)(3). A critical limit is defined in 21 CFR Part 123.3(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard."  
 
a.    Your firm’s HACCP plans for Salt-Cured Herring Fillets Packed in Oil or Vacuum-Packed and Salt-Cured Herring Fillets Packed in Salt Brine lists the critical limits, “Thaw time under cold running water and at ambient air temperature not to exceed 24 hours and thaw water temperature not to exceed 60°F at end of thaw cycle,” at “Thaw” critical control point that is not adequate to control scombrotoxin (histamine) formation. FDA recommends that control of time and ambient temperatures to prevent scombrotoxin formation instead of internal temperatures. In addition, your listed critical limit of 24 hours does not allow the product to be exposed to ambient temperatures above 40ºF during any of the subsequent handling steps.
 
b.    Your firm’s HACCP plans for Salt-Cured Herring Fillets Packed in Oil or Vacuum-Packed and Salt-Cured Herring Fillets Packed in Salt Brine includes does not list a critical limit for temperature during the brining process to control scombrotoxin formation. Your firm brines the fish for extended periods of time (e.g., 48 hrs., 72 hrs.). FDA recommends that the fish remain refrigerated (i.e. <40ºF) during the brining process. In addition, your firm should limit time and exposure to temperatures above 40ºF. The temperature of the brine should be monitored every two hours from the start of the brining process when it is 60° F until the brine reaches the room temperature of 38°F. That time should be considered part of the overall cumulative exposures to control scombrotoxin (histamine) formation.
 
c.    Your firm’s HACCP plans for Salt-Cured Herring Fillets Packed in Oil or Vacuum-Packed and Salt-Cured Herring Fillets Packed in Salt Brine does not list critical limits at the “eviscerate” critical control points to adequately control scombrotoxin (histamine) formation. Your plan fails to list a critical limit for time at this processing step to limit cumulative exposures to unrefrigerated conditions. If you choose not to monitor ambient temperatures, FDA recommends limiting cumulative exposures to 12 hours throughout processing.
 
d.    Your firm’s HACCP plan for “Receipt, Cold Storage, and Distribution of Caviar Products” lists a critical limit of, “refrigerated products must be chilled to a maximum temperature of 38°F using an adequate amount of ice or other appropriate cooling media or with mechanical refrigeration,” at the “Receiving of Fresh Fish Roe” critical control point that is not adequate to control pathogen growth and toxin formation for caviar received refrigerated. Specifically, monitoring the temperature of your product at receipt is not appropriate when products are transported for a significant period of time (i.e., more than 4 hours).  FDA recommends that HACCP plans for caviar delivered refrigerated (not frozen) include a critical limit for transit time of 4 hours or less from the time the caviar is removed from refrigeration at the shipping facility until it is received an chilled at your facility. When your firm receives refrigerated caviar that has been transported longer than 4 hours, your firm should establish a critical limit for transportation temperatures (i.e., 40ºF or below) and require that transportation temperatures are monitored continuously or monitor the adequacy of the ice surrounding the caviar.
 
4.    You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequencies for each critical control point to comply with 21 CFR Part 123.6(c)(4). Your firm’s HACCP plans for Salt-Cured Herring Fillets Packed in Oil or Vacuum-Packed and Salt-Cured Herring Fillets Packed in Salt Brine lists the following monitoring procedures and frequencies at the “Thaw” critical control point: 1. “thawing time” and “ambient air temperature” using a “temperature indicating and recording device and clock” at a frequency of “continuously with visual verification at least once per day during the working days” and 2. monitoring the “temperature of thaw water at end of thawing cycle” at a frequency of “every batch;” none of which are adequate to control scombrotoxin (histamine) formation. The fish are thawed under running water. The temperature of the thawing water should be monitored at the start of the process and every two hours subsequently. FDA recommends monitoring ambient conditions, the temperature of the thawing water is the ambient condition that directly affects the product.
 
5.    Predetermined corrective action plans included in a firm’s HACCP plan, to be taken whenever there is a deviation from a critical limit, must be appropriate to comply with 21 CFR Part 123.7(b).  
 
a.    Your corrective action plan for “Receipt, Cold Storage, and Distribution of Caviar Products” at the “Receiving of Fresh Fish Roe” critical control point to control pathogen growth and toxin formation is not appropriate. Your corrective actions when the temperature or cooling media critical limits are not met include the parameters to “examine internal temperature of product.” Sampling of internal temperatures cannot provide a safety assurance equivalent to assessing environmental conditions and exposure times.
 
b.    Your corrective action plan for Salt-Cured Herring Fillets Packed in Oil or Vacuum Packed and your Salt-Cured Herring Fillets Packed in Salt Brine at the “Finished Product Refrigerated Cold Storage,” and “Brine” or “First Brine” critical control point to control scombrotoxin (histamine) formation is not appropriate. Your listed corrective actions do not describe what will be done with the product, how the safety of the product will be evaluated, and how your firm will address the cause of the deficiency. 
 
6.    You must implement the monitoring procedures and frequencies that you have listed in your HACCP plan to comply with 21 CFR Part 123.6(b).
 
a.    Your firm did not implement your listed monitoring procedures” at the “Labeling of Finished Product” critical control point to control the food safety hazard of Clostridium botulinum growth and toxin formation. Our investigator observed that:
 
i.    Your labels for 131 g, 90 g and 45 g steel three-piece cans do not state “KEEP FROZEN” on the label as required by your HACCP plan.
 
ii.    Your labels for “Gourmanoff Gourmet Selected Salmon Caviar,” “Gourmanoff Kamchatka Style Salmon Caviar,” and “Gourmanoff Royal Pearl Salmon Caviar” in 7 oz. jars revealed that they do not state “KEEP FROZEN” on the label as required by your HACCP plan.
 
7.    You must immediately follow the procedures in 21 CFR Part 123.7 whenever any verification procedure, including the review of a consumer complaint, reveals the need to take corrective action to comply with 21 CFR Part 123.8(b). 
 
a.    The verification procedure identified in your HACCP plan for “Salt-Cured Fish Products Packed in Oil or Vacuum-Packed” includes “lab analysis of finished product 4 times yearly: 5.00% water phase salt content.” Specifically your firm did not take corrective action for the following products noted to contain less than 5.00% water phase salt content:
 
i.    Samples submitted to your private laboratory for quarterly water phase salt analyses on 6/17/14 for 1 piece of herring fillet salted no skin revealed a water phase salt content of 1.27%. This sample corresponds with fillets placed into process on 6/13/14 (approximately 176 lbs.) of Salt-Cured Herring Fillets Packed in Oil, with skin, packed for distribution on 6/16/14.
 
ii.    Samples submitted to your private laboratory for quarterly water phase salt analyses on 6/17/14 for 1 piece of herring fillet unsalted with skin revealed a water phase salt content of 1.37%. This sample corresponds with fillets placed into process on 6/13/14 (approximately 264 lbs.) of Salt-Cured Herring Fillets Packed in Oil, no skin, packed for distribution on 6/16/14.
 
iii.    Samples submitted to your private laboratory for quarterly water phase salt analyses on 2/9/15 for 1 piece of herring fillet salted no skin revealed a water phase salt content of 3.85%. This sample corresponds with fillets placed into process on 2/6/15 (approximately 264 lbs.) of Salt-Cured Herring Fillets Packed in Oil, no skin, packed for distribution on 2/7/15.
 
iv.    Samples submitted to your private laboratory for quarterly water phase salt analyses on 10/21/14 for 1 piece of herring fillet salted no skin revealed that the sample was analyzed for salt content only. The water phase salt content was not determined. This sample corresponds with fillets placed into process on 7/9/14 (approximately 88 lbs.) of Salt-Cured Herring Fillets Packed in Oil, no skin, packed for distribution on 7/12/14.
  
We may take further action if you do not promptly correct these violations. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. §381(a)), including placing them on "detention without physical examination," seize your product(s) and/or enjoin your firm from further violating the Act.
 
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation, such as HACCP and importer verification records, records that document the performance and results of your firm’s affirmative steps, HACCP and verification records associated with your activities as a domestic processor, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
 
Section 743 of the FD&C Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the FD&C Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. § 379j-31(a)(2)(B)).
For a domestic facility, FDA will assess and collect fees for re-inspection-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 FD&C Act.  Accordingly, FDA may assess fees to cover any re-inspection-related costs.
 
This letter may not list all the violations at your facility. You are responsible for ensuring that your seafood importer establishment operates in compliance with the Act and the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations for your fish or fishery products, including those that you import into the United States.
           
Please send your reply to the Food and Drug Administration, Attention: LCDR Catherine Beer, Compliance Officer, One Winners Circle, Suite 110, Albany, NY 12205. If you have questions regarding any issues in this letter, please contactLCDR Catherine Beerat 518-453-2314 x1015.
 
 
Sincerely,
/S/ 
Ronald M. Pace
District Director
New York District
 
 
Cc:      Mr. Alex Niyazov, General Manager, Co-Owner
            Royal Seafood Baza, Inc.
            175 Lake Avenue
            Staten Island, NY 10303-2727
 
            Mr. Gregory Tolston, CFO, Co-Owner
            Royal Seafood Baza, Inc.
            175 Lake Avenue
            Staten Island, NY 10303-2727
 
            Mr. Benny Shnayder, Silent Partner, Co-Owner
            Royal Seafood Baza, Inc.
            175 Lake Avenue
            Staten Island, NY 10303-2727
 
            Mr. Arthur Gavrelov, Employee Management, Co-Owner
            Royal Seafood Baza, Inc.
            175 Lake Avenue
            Staten Island, NY 10303-2727
 

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