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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Avole, Inc. 02-Sep-08

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 Fernandez Juncos Avenue
San Juan Puerto Rico 00901-3223

Telephone: 787-474-9500
FAX: 787-729-6658


September 2, 2008

WARNING LETTER
SJN-08-07

Certified Mail
Return Receipt Requested

Mr. Abel Velez Ortiz
President
Avole, Inc.
HC-06 Box 172082
San Sebastian, PR 00685

Dear Mr. Velez:

We inspected your seafood processing and importer establishment, located at Carr. 445, Km 1.1, San Sebastian, PR 00685 on June 19-20, 2008. 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), and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). 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 this part, 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). The specific requirements for imported fish and fishery products are set out in 21 CFR 123.12. As an importer of fish or fishery products, you must operate in accordance with the requirements of Part 123. 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 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 codfish frying mix is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it 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 violation was as follows:

1. 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). However your firm did not perform an affirmative step for the Codfish frying mix that you import from [redacted] located in the [redacted] The affirmative step may include any of the following:

(A) Obtaining from the foreign processor the HACCP and sanitation monitoring records required by this part that relate to the specific lot of fish or fishery products being offered for import; or

(B) Obtaining either a continuing or lot-by-lot certificate from an appropriate foreign government inspection authority or competent third party certifying that the imported fish or fishery product is or was processed in accordance with the requirements of this part; or

(C) Regularly inspecting the foreign processor's facilities to ensure that the imported fish or fishery product is being processed in accordance with the requirements of this part; or

(D) Maintaining on file a copy, in English, of the foreign processor's HACCP plan, and a written guarantee from the foreign processor that the imported fish or fishery product is processed in accordance with the requirements of the part; or

(E) Periodically testing the imported fish or fishery product, and maintaining on file a copy, in English, of a written guarantee from the foreign processor that the imported fish or fishery product is processed in accordance with the requirements of this part; or

(F) Other such verification measures as appropriate that provide an equivalent level of assurance of compliance with the requirements of this part.

We acknowledge receiving your letter dated June 23, 2008, in response to the FDA-483-Form, Inspectional Observations that was issued and discussed with you during our inspection. We found your response inadequate in that you did not provide any specifics on the documentation that you will be implementing or when you will have in-place your HACCP plan requirements. In addition, you did not provide a decision concerning to continue or to cease the importation of your Codfish frying mix.

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.

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 and importer verification records, records that document the performance and results of your firm's affirmative steps, HACCP and verification records associated with your activities as a domestic processor, 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). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations for the fish or fishery products that you import into the United States.

Your written reply should be addressed to the Food and Drug Administration, Attention: Carlos A. Medina, Compliance Officer, at 466 Fernandez Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions concerning the violations noted please contact Mr. Medina at (787) 474-9538 or by electronic mail at carlosa.medina@fda.hhs.gov.

Sincerely,

/S/

Maridalia Torres
District Director
San Juan District