Inspections, Compliance, Enforcement, and Criminal Investigations

Caviar Petrossian S.A. 8/2/18

 

  

Black HHS-Blue FDA Logo

 

 

 
5001 Campus Drive
College Park, MD 20740

 

WARNING LETTER

AUG 2 2018

VIA EXPRESS DELIVERY

Armen Petrossian, Chief Executive Officer
Caviar Petrossian S.A.
Porte 47 Cap18 Voie A, 43 rue de L' Evangile
Paris 75018 France

Reference# 560520

Dear Mr. Petrossian:

The U.S. Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility Caviar Petrossian S.A., located at Porte 47 Cap18 Voie A, 43 rue de L'Evangile, 75018 Paris, France on April 25-26, 2018. That inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). That inspection resulted in FDA's issuance of an FDA 483, lnspectional Observations, listing the observations made at your firm at the conclusion of the inspection. We acknowledge receipt of your response sent via email on May 4, 2018. Your response included your revised HACCP plan for "refrigerated vacuum packaged liquid caviar," dated May 2018; blank monitoring records; and a labeling control document. However, our evaluation of the documentation revealed that your response was not adequate, as further explained in this letter.

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 vacuum packaged liquid caviar product is adulterated, in that it has been prepared, packed, or held under conditions whereby it may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the 4th Edition of the Fish and Fishery Products Hazards and Controls Guidance (the Hazards Guide) through links on FDA's home page at www.fda.gov.

Your significant deviations are as follows:

1. 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 123.6(c)(4). However, your firm's HACCP plan for your refrigerated vacuum packaged liquid caviar entitled "Caviar Petrossian," submitted with your response to the FDA 483,

a) Lists monitoring frequencies at the "(b)(4)" critical control point that are not adequate to control Clostridium botulinum growth and toxin formation, associated with your critical limit for water phase salt (WPS). Specifically, your HACCP plan (b)(4)". However, in order to consistently ensure the safety of incoming product, FDA recommends testing every batch at receipt to ensure the WPS is greater than 5%.

b. Lists monitoring frequencies the "(b)(4)" critical control point that are not adequate to control the food safety hazard of Clostridium botulinum growth and toxin formation, associated with temperature monitoring during transit to your facility (i.e., listed as "(b)(4)"). Specifically, your HACCP plan (b)(4) However, as a secondary processor your monitoring procedures should list controls to ensure the products were held at your listed critical limit of (b)(4)°C ((b)(4)°F) or below for the entire duration of the transit period to your facility. For example, FDA recommends records showing continuous time and temperature at temperatures at or below 4.4°C (40°F) throughout transit, or the products are completely surrounded by ice at the time of delivery; or the products are delivered under an adequate quantity of frozen gel packs and the internal product temperature at delivery is below 4.4°C (40°F); or if transit time is short (i.e., less than 4 hours), the internal temperature of the product at delivery is below 4.4°C (40°F).

2. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21CFR123.7(b). However, your corrective action plan listed in your HACCP plan entitled "Caviar Petrossian," submitted with your response to the FDA 483 is not appropriate. Specifically, at the "(b)(4)" critical control point your listed corrective actions are not adequate to control the hazard of Clostridium botulinum growth and toxin formation. Your corrective actions must ensure adulterated product does not enter commerce. FDA recommends you revise your corrective action to describe the disposition of the affected product, such as: evaluating the cumulative time and temperature exposures for food safety; destroy affected products; or divert the products to a non-food use, in addition to the corrective actions listed in your plan.

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these deviations. More specifically, your response should include documentation reflecting the changes you made, such as a copy of your revised HACCP plan, five (5) consecutive days of completed monitoring records (i.e., complete sets of monitoring records for the production of 5 production date codes of products) to demonstrate implementation of the plan, and any additional information that you wish to supply that provides assurance of your intent to fully comply now and in the future with the seafood HACCP regulation. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.

If you do not respond or if we find your response inadequate, we may take further action. 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 (DWPE). FDA's DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA's Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the seafood HACCP regulation is Import Alert #16-120. You may view this alert at: http://www.accessdata.fda.gov/cms_ia/ialist.html.

This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the seafood HACCP regulation, and the Good Manufacturing Practice regulations (21CFR110 and 21CFR117 Subpart B). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

Additionally, 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 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)). For a foreign facility, FDA will assess and collect fees for re-inspection-related costs from the U.S. Agent for the foreign 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 re-inspection-related costs. Please consider providing a copy of this letter to your U.S. Agent.

Please send your reply to Food and Drug Administration, Attention: Standra Purnell, Compliance Officer, Food Adulteration Assessment Branch (HFS-607), Division of Enforcement, Office of Compliance, 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Ms. Purnell via email at standra.purnell@fda.hhs.gov. Please reference CMS #560520 on any submissions and within the subject line of any emails to us.

Sincerely,
/S/
William A. Correll
Director
Office of Compliance
Center for Food Safety
and Applied Nutrition

Page Last Updated: 10/10/2018
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