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WARNING LETTER

Fabrica Confecciones Soto, Inc. MARCS-CMS 480775 —


Recipient:
Fabrica Confecciones Soto, Inc.


United States

Issuing Office:
San Juan District Office

United States


  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 San Juan District
Compliance Branch 
466 Fernández Juncos
San Juan, Puerto Rico
00901-3223
 
Telephone: 787-729-8500
FAX: 787-729-8765

DEC 18, 2015 

WARNING LETTER
16-SJN-WL-03
 
VIA UNITED PARCEL SERVICE
NEXT DAY – SIGNATURE REQUIRED
 
 
Mr. Ismael Soto Cruz
President & Owner
Fábrica & Confecciones Soto, Inc
81 Calle Autonomía
Canóvanas, Puerto Rico 00729-3248
 
Dear Mr. Soto:
 
The U.S. Food and Drug Administration (FDA) inspected your food manufacturing facility located at 81 Calle Autonomía, Canóvanas, PR, from 07/08/2015 through 07/24/2015.  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. 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 products “Tacos de Camarones”, (translation to English: “Shrimp Tacos”) are adulterated, in that they have been 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.
 
Your significant seafood HACCP violation is as follows:
 
You must conduct or have conducted your 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 have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.” However, your firm’s HACCP plan for your seafood product “Tacos de Camarones”, (translation to English: “Shrimp Tacos”), manufactured with shrimp and imitation crab meat, does not list the food safety hazard of undeclared allergens (shrimp, fish, crab, wheat, eggs, soy, and milk) or undeclared food and color additives (sulfiting agents and FD&C Yellow #5).
 
On August 12, 2015, we received your written response to the FDA-483 form dated July 24, 2015, issued to your firm during the closing of the inspection.  We have completed the review of your written response, and found that your corrections were not comprehensive and additional evidence is needed to demonstrate sustained compliance with applicable regulatory requirements. For example, your firm did not provide a complete revised copy of your HACCP plan. According to your response, it appears that your firm is not identifying the need for a critical control point at labeling review.
 
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you have taken to correct these violations. Your response should include documentation, such as a copy of any revised HACCP plan or plans; at least five (5) completed production days-worth of monitoring records to demonstrate that you have implemented the revised plan or plans; any verification records; and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within fifteen (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 action to seize your product(s) and/or enjoin your firm from operating. At the conclusion of the inspection on July 24, 2015, you committed to implement corrective and preventive actions concerning the referenced deviations. A HACCP plan, on its own, does not warrant compliance unless it is demonstrated that the HACCP plan is adequate and is being followed. 
 
This letter may not list all the violations at your facility.  You are responsible for ensuring that your processing plant operates in compliance with the Act, 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.
 
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 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.
 
If you have any questions about this letter, you can contact Compliance Officer Marilyn Santiago at (787) 729-8707, or by electronic mail at: marilyn.santiago@fda.hhs.gov.
Your response to this letter should be sent to the Food and Drug Administration, San Juan District Office, 466 Fernández Juncos Avenue, San Juan, PR 00901-3223, to the attention of Ms. Maridalia Torres, District Director.
 
Sincerely,
/S/ 
Maridalia Torres
San Juan District Director

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