Inspections, Compliance, Enforcement, and Criminal Investigations
Empresas Y-nuina Inc. 12-Jan-06
Department of Health and Human Services
Public Health Service
San Juan District Office
January 12, 2006
RETURN RECEIPT REDUESTED
Mr. Enrique Mangual Flores
Empresas Y-nuina Inc .
P.O. Box 1661
Canovanas, PR 00729
Dear Mr. Mangual:
FDA inspected your food manufacturing facility, located at Rd 185, Km 0.8 Urb. Industrial, Canovanas, Puerto Rico, 00729, on November 9-21, 2005. We found that you have repeated violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulations, Title 21, Code of Federal Regulations, Part 123 (21 CFR 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 fish and fishery hereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulations, 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:
You have not 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(s) for the preparation of frozen crab tacos and crab-filled plantain fritters to control the hazard of microbiological contamination.
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 frozen blue crab meat imported from Venezuela.
You must monitor the conditions and practices during processing with sufficient frequency to ensure, at minimum, conformance with Current Good Manufacturing Practices for Foods (21 CFR Part 110) to comply with 21 CFR 123.11(b). However, the following unsanitary conditions were observed at your facility: beverage bottles on workstations where pizza empanadillas and lasagna tacos were processed, lack of sanitary paper in the ladies toilet's facility, standing water on the floor inside the cheese cooler, and heavy condensation inside the cheese cooler and on several cooling fans which are located above finished products (potato balls with meat and chicken tacos).
You must maintain sanitation control records that, at a minimum, document the monitoring and corrections prescribed by 21 CFR 123.11(b) to comply with 21 CFR 123.11(c). However, there was no evidence of sanitation monitoring activities or control records maintained in your facility.
This is the second inspection that documents your failure to comply with the HACCP regulations. We sent you an Untitled Letter on May 20, 1998, addressing the same violations that the investigator found in this inspection. We are including a copy of the untitled letter with this correspondence because you indicated during the inspection that you did not recall receiving a letter from FDA. We are also including a copy of your response letter dated April 11, 1998, in which you agreed to comply with the HACCP regulation. 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 regulations and the Current Good Manufacturing Practice regulations. 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