Inspections, Compliance, Enforcement, and Criminal Investigations
Trafon Group, Inc. dba Star Meat 3/23/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
San Juan District
466 Fernández Juncos
San Juan, Puerto Rico 00901-3223
Telephone: 787-474-9500FAX: 787-729-6658
MAR 23, 2012
Mr. Carlos A. Trapaga Fonalledas
CEO & President
Trafon Group, Inc.
Garden Hills Plaza PMB 342
#1353, Road 19
Guaynabo, PR 00966-2700
Dear Mr. Trapaga Fonalledas:
We inspected your seafood processing and importer facility located at Bldg. C, #1229 Mercado Central, Zona Portuaria Puerto Nuevo, San Juan, PR 00922 from January 26, 2012 through February 6,2012. 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 CPR 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).
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 Part 123. 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 frozen seafood products, such as shrimp, octopus, and tilapia; and frozen fish such as Mahi-Mahi, Saithe, Corvina, Kingfish, Codfish, and other fish and fishery products processed by your firm 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 violations were as follows:
1. As an importer, you must implement an affirmative step which ensures that the fish and fishery products you import are processed in accordance with the seafood HACCP regulation, to comply with 21 CFR 123.12(a)(2)(ii). In addition, you must have product specifications that are designed to ensure that the fish and fishery products you import are not injurious to health, to comply with 21 CFR 123.12(a)(2)(i). However, your firm did not perform an affirmative step and does not have a product specification for at least the following products:
| Entry number|| Date|| Product|| Origin|
| 1-CDX-0053719-3||03/30/2011||Frozen pre-cooked shrimp||Vietnam|
| 2-CDX-0053639-3||05/04/2011||Frozen Seafood Mix, octopus, and razor fish||Spain|
| 3-CDX-0053708-6||05/11/2011||Frozen cooked shrimp|
| 4-CDX-0050717-0||06/16/2010||Atlantic Pollock (Saithe)||Norway|
2. You must conduct a hazard analysis 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 critical control points, to comply with 21 CFR 123.6 (a) and (c)(2). A critical control point is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However, your firm's HACCP plan for "frozen raw fish" products does not list a critical control point for controlling the food safety hazard(s) of metal fragments during the "slicing, cutting, trimming" process step.
During the inspection, the FDA Investigator observed that your processing plant is not equipped with a metal detector and does not have adequate control measures to prevent metal inclusion during the cutting process.
3. You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b) to comply with 21 CFR 123.11(c). However, your firm did not maintain sanitation monitoring records for prevention of cross-contamination from insanitary objects, protection of food, food packaging material, and food contact surfaces from adulteration, and exclusion of pests, relevant for the cutting and re-packaging operations conducted at your processing plant.
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.
At the conclusion of the inspection on February 06,2012, you verbally promised our Investigator that you would immediately begin correcting the referenced deviations and submit a written response to FDA within fifteen (15) days. However, as of the date of this letter, we have not received a written response from you. You were previously notified of your failure to comply with the seafood HACCP regulation during our previous inspection of June 2011.
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 plan, sanitation monitoring records, and importer verification records that document the performance and results of your firm's affirmative steps, 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 Practices 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 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 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. 379j31(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 Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please send your reply to the Food and Drug Administration, Attention: Marilyn Santiago, Acting Compliance Officer, at 466 Fernandez Juncos Avenue, San Juan, PR 00901-3223. If you have questions regarding any issues in this letter, please contact Ms. Santiago via email at email@example.com or via telephone at (787) 474-9535.
San Juan District