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WARNING LETTER

Shree Datt Aquaculture Farms MARCS-CMS 588773 —


Delivery Method:
Via Express Delivery
Product:
Food & Beverages

Recipient:
Recipient Name
Dattubhai Tandel
Recipient Title
Managing Director
Shree Datt Aquaculture Farms

270/1, At & Post Talodh, Billimora, District Navsari
Taluka-Gandevi 396321
Gujarat
India

Issuing Office:
Center for Food Safety and Applied Nutrition

5001 Campus Drive
College Park, MD 20740-3835
United States


AUG 22, 2019

WARNING LETTER

Reference # 588773

Dear Mr. Tandel:

The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, Shree Datt Aquaculture Farms. located at 270/1 At & Post Talodh, Bilimora, Gandevi, Gujarat, 396321, India on May 15-16, 2019.  During that inspection, we found that you had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123).  At the conclusion of that inspection, the FDA investigator issued an FDA 483, lnspectional Observations, listing the observations made at your firm.  We acknowledge receipt of your responses sent via email on May 30, 2019 and July 20, 2019 to FDA 483 and to the FDA email dated July 2, 2019.  Your response dated July 20, 2019 included a revised HACCP plan entitled "Cooked and Peeled/PD PV/PND/PDTO/PDTO BFLY IQF," dated July 5, 2019, a written corrective action report, cooking validation record, and completed monitoring records.  However, our evaluation of your responses revealed they were not adequate, as further described 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 cooked shrimp are adulterated, in that they have been prepared, packed, or held under conditions whereby they 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 to comply with 21 CFR 123.6 (c)(4).  However, your firm's revised HACCP plan entitled "Cooked  and Peeled /PD PV/PND/PDTO/PDTO BFLY IQF"  dated July 5, 2019 lists monitoring procedures and frequencies that are not adequate to control pathogenic bacteria survival  through cooking.  Specifically, at the "(b)(4)" critical control point, your plan lists,

a.   "(b)(4)".  FDA recommends that firms monitor the cooking temperature (steam temperature) using a continuous temperature-recording device (e.g., a recording thermometer) with continuous monitoring by the device itself with a visual check of the recorded data at least once per day.

b.    "(b)(4)".  However, monitoring the belt speed with a stop watch does not ensure conformance with your listed critical limit for the time ((b)(4)) for the products to be held at a listed core temperature of 79 Deg. C. Monitoring the belt speed with a stop watch will only indicate how long the product was in the cooker.

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., records for the production of 5 production date codes of the 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 applicable laws and regulations.  Submission of the information in English will assist in our review.  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 believe that your product is not in violation of the Act, include your reasoning and any supporting information for our consideration.

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.

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.

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 regulation (21 CFR 117 Subpart B).  You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

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 #588773 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