Inspections, Compliance, Enforcement, and Criminal Investigations
Best Seasonings Group Inc. dba Sofrito Montero Inc. 2/26/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|San Juan District |
466 Fernández Juncos
San Juan, Puerto Rico
Mr. Efraín Montero
Best Seasonings Group Inc
54 Parque Industrial Amuelas
Road 592 Desvio Victor Cruz #54
Juana Diaz, PR 00795
Dear Mr. Montero:
The United States Food and Drug Administration (FDA) inspected your condiments and seafood manufacturing establishment located at Road 592 Desvio Victor Cruz #54, Juana Diaz, Puerto Rico, from December 04 through December 20, 2012 (not all dates inclusive). 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 § 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 operates 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 seafood products, specifically your fully cooked, ready-to-eat product “El Rey Salmorejo de Jueyes” (Crabmeat stew), is adulterated, in that it has been held under unsanitary conditions whereby it may have been rendered injurious to health.
You must conduct or have conducted a 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 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 your fish product “El Rey Salmorejo de Jueyes” (Crabmeat stew) to control related food safety hazards such as growth of Listeria monocytogenes.
We acknowledge receipt of your written response letter dated December 27, 2012 to the Inspectional Observations (Form FDA-483) issued to you on December 20, 2012. In response to Observations No. 1 and No. 2, you included a recently developed Hazards Analysis, and a HACCP plan “to be implemented,” and our review found them inadequate in that:
1. According to your response, your newly developed HACCP plan “will be implemented;” however, your response did not specify when. A HACCP plan, on its own, does not warrant compliance unless it is demonstrated that the plan is adequate, implemented, and being followed.
2. Your HACCP plan does not include the “Cooling” processing step as a Critical Control Point (CCP). Your product is labeled as fully cooked, and thus you are recognizing that it might be consumed without further cooking. You must identify the post-cook processing step “Cooling” as a CCP for your product.
3. Evidence was not provided to support compliance with the requirements established under 21 CFR § 123.10, to demonstrate that your new HACCP plan was developed by an individual who successfully completed training in the application of HACCP principles or who is otherwise qualified through job experience to perform these functions.
4. Your Hazard Analysis does not identify the hazard of pathogenic bacteria growth (i.e. Listeria monocytogenes), as relevant for the “Cooling” processing step during the manufacturing of your fish product “El Rey Salmorejo de Jueyes” (crabmeat stew). Pathogenic bacteria can be introduced while handling the already cooked product, and bacterial growth to unsafe levels may happen due to time and temperature abuse.
5. FDA recommends that firms conduct a label review for each batch of labels comparing the ingredient statements with the product formulations to ensure all allergenic substances are accurately declared. Your recently developed Hazard Analysis does not include undeclared allergens as a potential food safety hazard. You need to include a labeling critical control point in your HACCP plan to ensure that all allergenic substances are always adequately declared on your fish product label.
We may take further action if you do not promptly correct these violations. 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 December 20, 2012, you verbally promised our Investigator that you would immediately begin correcting the identified deviations.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specifics you are doing to correct these violations. If you cannot complete all corrections before your response, you should explain the reason for your delay and state when any remaining violations will be corrected.
This letter may not list all the violations at your facility. You are responsible for ensuring that your seafood manufacturing establishment operates in compliance with the Act, seafood HACCP (21 CFR Part 123), and Current Good Manufacturing Practices in Manufacturing, Packing or Holding Human Food (21 CFR Part 110) regulations. It is your responsibility to use procedures to prevent further violations of the Act and all applicable regulations for your fish or fishery products.
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. § 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 Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please send your reply to the Food and Drug Administration, Attention: Ms. Maridalia Torres, District Director, at 466 Fernández Juncos Avenue, San Juan, PR 00901-3223. If you have questions regarding any issues in this letter, please contact Ms. Marilyn Santiago, Compliance Officer, via email at Marilyn.Santiago@fda.hhs.gov or via telephone at (787) 474-9535.
San Juan District