Inspections, Compliance, Enforcement, and Criminal Investigations

Lupa Gourmet Inc. 3/21/16

  

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                                       

 

March 21, 2016
 
 WARNING LETTER NYK-2016-30 
 
 
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
 
Mr. Paolo Mannoni
President
Lupa Gourmet, Inc.
330 Coster Street
Hunts Point, NY 10474
 
Dear Mr. Mannoni:
 
We inspected your seafood processing and importer establishment, located at 330 Coster Street Hunts Point, NY 10474 between December 16, 2016 and December 23, 2016.  We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123), and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). 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).
 
As an importer of fish or fishery products, you must operate in accordance with the requirements of 21 CFR 123.12. In accordance with 21 CFR 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 Part123. 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 ready-to-eat, refrigerated, vacuum packaged, whole mullet roe (Bottarga di Muggine) and ready-to-eat, refrigerated, anchovy fillets marinated in oil (Filetti di Alici) are 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.
 
We received your firm’s responses dated January 11, 2016, regarding our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to you on December 23, 2016. We address your responses below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
 
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 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: 
  • Refrigerated, ready-to-eat, vacuum packed, whole mullet roe (Bottarga di Muggine) to control the hazards of Clostridium botulinum toxin formation, pathogenic bacteria growth and toxin formation;
  • Refrigerated, ready-to-eat, anchovy fillets marinated in oil (Filetti di Alici) to control the hazards of Clostridium botulinum toxin formation, scombrotoxin (histamine) formation, and pathogenic bacteria growth and toxin formation
Your response indicates you would prepare a HACCP plan once you have completed the seafood HACCP training in January 2016. However, to date we have not received any supplemental responses forwarding a HACCP plan or confirmation that the training was completed.
 
2.    You must implement an affirmative step which ensures that the fish and fishery product(s) you import are processed in accordance with the seafood HACCP Regulation, to comply with 21 CFR123.12(a)(2)(ii). However, your firm did not implement an affirmative step for ready-to-eat, refrigerated, vacuum packaged, whole mullet roe (Bottarga di Muggine) manufactured by (b)(4), and ready-to-eat refrigerated anchovy fillets marinated in oil and vinegar (Filetti Di Alici) manufactured by (b)(4).
 
Your response fails to report any corrective action taken or planned with respect to this observation.
 
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
 
Additional comments regarding your January 11, 2016 response to the FDA 483, List of Inspectional Observations:
 
Your response indicates you plan to check temperatures twice a day recording the results on a clipboard. This monitoring procedure is not adequate to control the potential food safety hazards during extended time periods including when the facility is not operating such as nights, weekends and holidays. FDA recommends continuous monitoring during storage, using a continuous temperature-recording device (e.g., a recording thermometer), with a visual check of the recorded or generated data at least once per day.
 
While your response did not include a copy of your HACCP plan, you stated in your response that your marinated anchovies will be checked for temperature upon delivery. Monitoring internal temperatures is only appropriate for products that have been transported for a limited period of time (e.g., less than 4 hours). However, when products have been in transit for longer time periods, FDA recommends that you monitor transport conditions (e.g. adequacy of cooling media or transport temperatures) to ensure that your products have been held under safe conditions throughout transport. In addition, your response did not address the violations observed for other fish and fishery products you receive and store, such as your refrigerated ready to eat vacuum packed whole mullet roe. 
 
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.
 
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.
 
Section 743 of the Act, (21 USC 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 non-compliance 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 USC 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 non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
 
Your written response should be sent to Lillian C. Aveta, Compliance Officer, U.S. Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, New York 11433. If you have any questions about this letter, please contact Compliance Officer Lillian C. Aveta at (718) 662-5576 or by e-mail at Lillian.Aveta@fda.hhs.gov.
 
Sincerely,
/S/ 
Ronald M. Pace
District Director
New York District

Page Last Updated: 03/24/2016
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