Inspections, Compliance, Enforcement, and Criminal Investigations
Pedro Barba & Sons Inc. 12/5/05
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
San Juan District Office
December 5, 2005
RETURN RECEIPT REQUESTED
Mr. Pedro Barba de La Cruz
Pedro Barba & Sons Inc.
P.O. Box 363932
San Juan, PR 00936-3932
Dear Mr. Barba:
We inspected your seafood processing facility, located at Building B, Mercado Central Zona Portuaria, Puerto Rico, 00922 on September 14-19, 2005. 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 ofa 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, various refrigerated fish and fishery products, including (b)(4) species, such as refrigerated (b)(4) and (b)(4) 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.
In addition, review of your product labels reveals that your (b)(4) products are misbranded within the meaning of Section 403 [21 U.S.C. § 343] of the Act.
Your significant violations were as follows:
• You must conduct or have conducted for you 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 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(s) for refrigerated pickled (b)(4) to control Clostridium botulinum and histamine formation, refrigerated smoke (b)(4) fillets to control pathogen growth/toxin formation and histamine fannation, and refrigerated salted (b)(4) to control the hazard of histamine formation while these products are transported to and held by your firm. FDA recommends that you continuously monitoring transport and storage temperatures at or below (b)(4) of monitor for the presence of adequate ice/cooling media surrounding the products.
• 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 Part 123.12(a)(2)(ii). However, your firm did not perform an affirmative step for refrigerated heavy salted (b)(4) from (b)(4) refrigerated pickled (b)(4) from (b)(4) dried salted (b)(4) fillets from (b)(4) and salted (b)(4) fillets from (b)(4)
We have reviewed the label of the imported (b)(4) fillets, collected by the Investigator during the course of the inspection. OUf review reveals that this label causes the product to be misbranded in violation of Section 403(e)(1) of the Act and 21 CFR Part 101.5(a) in that the label lacks the name and place of business of the manufacturer, packer. or distributor.
We may take further action if you do not promptly correct these violations. For instance. we may take further action to seize your product(s) and/or enjoin your firm from operating.
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 verification records, 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 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.
Please send your reply to the Food and Drug Administration, Attention: Margarita Santiago, Compliance Officer. 466 Fernandez Juncos Avenue, San Juan, Puerto Rico, 00901-3226. If you have questions regarding any issues in this letter, please contact Ms. Santiago at 787-474-4789.
David Gan, M.D., Dr. PH, MPH
Acting District Director
San Juan District