Inspections, Compliance, Enforcement, and Criminal Investigations

Vinill Inc. 9/21/18

 

  

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Office of Human and Animal Food Operations East
Division 1
 

 

WARNING LETTER
CMS# 564925
 
 
UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
September 21, 2018 
 
Mr. Leonid Kats, Owner
Vinill Inc.
4801 2nd Ave
Brooklyn, NY 11232-4220
 
Dear Mr. Kats:
 
We inspected your seafood processing and distribution facility located at 4801 2nd Ave, Brooklyn, NY 11232 on August 29, 2018 and September 4, 2018.  We found you have 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).
 
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). Accordingly, your refrigerated, ready-to-eat, vacuum packaged, smoked paddlefish is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it 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 Internet home page at www.fda.gov.
 
We acknowledge receipt of your electronic response email dated September 6, 2018 responding to the Form FDA-483, Inspection Observations (FDA-483), issued to you on September 4, 2018. We address the adequacy of specific corrective actions below. 
 
Your significant violations were as follows: 
  • You must conduct, or have conducted for you a hazard analysis for each kind of fish or fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm does not have a HACCP plan for your refrigerated, ready-to-eat, vacuum packaged, smoked paddlefish to control the food safety hazard of Clostridium botulinum growth and toxin formation. 
Once you have conducted a hazard analysis for your seafood products, your HACCP plan must, at a minimum, list the hazards that are reasonably likely to occur, and include appropriate critical control points, critical limits, monitoring procedures, recordkeeping activities, etc., to ensure that the food safety hazards are controlled to comply with 123.6(c).
 
Your September 6, 2018 email included a photo of a receiving monitoring log and a refrigerated storage monitoring log. However, your response is inadequate because you did not provide any information that indicates you have conducted a hazard analysis and implemented an adequate HACCP plan for your refrigerated, ready-to-eat, vacuum packaged, smoked paddlefish.
 
This letter is not intended to be an all-inclusive list of the violations that exist in connection with your products. You are responsible for ensuring that your food manufacturing and seafood processing establishment operates in compliance with the Act and all applicable regulations, including the seafood HACCP regulation (21 CFR Part 123). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
 
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
 
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 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 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)). 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 re-inspection-related costs.
 
You should respond in writing within fifteen (15) working days from the date you receive 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 verification records, 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.                                                                                  
 
Please send your reply to the Food and Drug Administration, Attention: Scott M. Loughan, Compliance Officer, 462 Welcome Center Road, Swanton, VT 05488. If you have questions regarding any issues in this letter, please contactMr. Loughanat 781-587-7619 or scott.loughan@fda.hhs.gov.
 
 
Sincerely,
/S/
Ronald Pace
Program Division Director
Office of Human and Animal Food Operations East – Division 1

Page Last Updated: 09/27/2018
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