WARNING LETTER

Merchants Market St. Croix LLC MARCS-CMS 575447 — March 11, 2019

Reference #:: 19-HAFE4-WL-05/CMS No. 575447
Product:: Food & Beverages
Seafood/Seafood Product

Recipient:: Recipient Name

Mr. Rick Wilson; Recipient Title

President; Merchants Market St. Croix LLC; 4000 Estate Diamond
Christiansted
St. Croix VI 00820-5215
U.S. Virgin Islands

Issuing Office:: Division of Human and Animal Food Operations East IV; 466 Avenida Fernandez Juncos
San Juan 00901-3223
Puerto Rico; 787-729-8500

March 11, 2019

WARNING LETTER

VIA UNITED PARCEL SERVICE
NEXT DAY - SIGNATURE REQUIRED

Mr. Rick Wilson, President
Merchants Market St. Croix, LLC
4000 Estate Diamond
Christiansted
St. Croix, VI 00820-5215

Dear Mr. Wilson:

The United States Food and Drug Administration (FDA) inspected your seafood warehouse and distribution facility located at #4000 Estate Diamond, Christiansted, St. Croix, USVI, from November 13, 2018 through November 15, 2018. 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 123). In accordance with 21 CFR Part 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 pasteurized canned crabmeat product is adulterated, in that it has been held under insanitary 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. The Hazards Guide, which provides our recommendations regarding identification and control of food safety hazards reasonably likely to occur for your fish and fishery products, can be found on our web site at: http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/seafood/ucm2018426.htm

Your significant violations are as follows:

You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you store and distribute 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 pasteurized canned crabmeat to control the food safety hazards of Clostridium botulinum toxin formation and pathogenic bacteria growth due to temperature abuse. During the inspection, your firm indicated that you receive pasteurized canned crabmeat in refrigerated shipping containers which are in transit to your facility for a period of at least three (3) days. As such, your firm should have a HACCP plan that includes receiving controls which ensure the refrigerated canned crabmeat products were continuously held at or below 40°F throughout transit.

Your firm indicated that it is your practice to freeze the crabmeat upon receipt at your facility and that you further distribute the product frozen. However, it is necessary that you implement a HACCP plan that addresses the hazard of Clostridium botulinum toxin formation and pathogenic bacteria growth due to temperature abuse at refrigerated receipt, even if you subsequently freeze the products.

On December 12, 2018, we received your written response proposing corrective actions for the five (5) observations that were listed in Form FDA-483, Inspectional Observations, issued to your firm’s General Manager during the close-out meeting on November 15, 2018. Your response is inadequate in that you proposed to develop and implement a HACCP plan for your refrigerated products (including pasteurized canned crabmeat) but you did not propose an implementation date for this action and your mitigation action of continuing freezing the products upon receipt will not control the product related hazards during transit as explained above in this letter. You also indicated that a Standard Operating Procedure (SOP) for transit temperature monitoring has been implemented, but no records are included that could help in demonstrating its successful implementation. Further, in your response you proposed to maintain the temperature monitoring related records in your facility for a minimum of 90 days. Your proposed record retention timeframe is not in compliance with the requirements established under 21 CFR Part 123.9.

This letter may not list all the deviations at your facility. You are responsible for ensuring that your warehouse and distribution facility operates in compliance with the Act and all applicable regulations, including the seafood HACCP, Title 21, Code of Federal Regulations, Part 123
(21 CFR Part 123), and the current Good Manufacturing Practice Hazard Analysis, and Risk- Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117, Subpart B). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations. More specifically, your response should include documentation and information that would assist us in evaluating your corrections, such as documentation reflecting the changes you made, like a copy of your implemented HACCP plan, five (5) consecutive days of completed temperature monitoring records to demonstrate implementation of the plan, and any additional information that you wish to provide that offers 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 working days, you should explain the reason for your delay and state when you will correct any remaining violations. If you believe you have complied with FDA regulations, include your reasoning and any supporting information for our consideration.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in FDA taking regulatory action without further notice, such as seizure or injunction. 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 mean 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.

Your written response should be directed to the Food and Drug Administration, attention to: Mr. Ramon Hernández, District Director, at 466 Fernández Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions regarding this letter, please contact Ms. Marilyn Santiago, Compliance Officer, at (787) 729-8707 or via email at Marilyn.santiago@fda.hhs.gov.

Sincerely yours,
/S/
Ramon A. Hernandez
District Director, San Juan District Office, and
Program Division Director
Office of Human and Animal Food Operations
Division IV East

Copy to:
Nathanial Brownsdon, General Manager
Merchants Market St. Croix LLC
4000 Estate Diamond
Christiansted
St. Croix, VI 00820-5215