Inspections, Compliance, Enforcement, and Criminal Investigations
Medina & Medina, Inc.11/21/05
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
San Juan District
November 21, 2005
RETURN RECEIPT REQUESTED
Mr. Jose Alfredo Medina
Owner & President
Medina & Medina, Inc.
P.O. Box 362200
San Juan, P.R. 00936-2200
Dear Mr. Medina:
On September 9, 2005, the Food and Drug Administration (FDA) initiated an inspection of your facility located at 505 Street At Industrial Park Dr. Mario Julia, San Juan, Puerto Rico 00920. The inspection was conducted to determine your firm's compliance with FDA's seafood processing regulations (21 CPR 123). The inspection was completed on September 13, 2005, and FDA's findings were presented to Mr. Jose M. Medina Sanchez.
During our inspection, the FDA investigator observed serious recurrent deviations from the seafood Hazard Analysis and Critical Control Points (HACCP) regulations, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). In accordance with 21 CPR 123.12, failure of an importer to have and implement an Importer Verification procedure that complies with this section or otherwise operate in accordance with the requirements of this part, renders the fish and fishery products to be 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 products are adulterated, in that they have been prepared, packed, or held under unsanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You may find the Act and the seafood HACCP regulations through links in FDA's home page at www.fda.gov.
The requirements are as follows:
• You must have and implement written verification procedures, including product specifications and affirmative step(s), that are designed to ensure that the fish and fishery products offered for import into the United States are processed in accordance with the HACCP regulations, to comply with 21 CFR 123.12(a)(2)(i) and 21 CFR 123.12(a)(2)(ii).
• You must have evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with the HACCP regulations. to comply with 21 CFR 123(d).
You have failed to comply with the above-mentioned requirements in that:
• Your firm does not have product specifications to ensure that the fish and fishery products you import from Italy and Spain are processed in compliance with the seafood HACCP regulations. Because these two countries do not have an active memorandum of understanding (MOD) or similar agreement with the FDA, the fish and fishery products imported from these countries are required to have product specifications as well as affirmative steps to ensure the products are processed in compliance with seafood HACCP regulations. Examples of fish and fishery products being imported from these countries are: ready-to-eat octopus salads imported from Italy as well as hake bites, whiting fillets breaded, breaded fish fingers. tuna pies, squid rings, and salted cod imported from Spain.
• Your firm has not implemented the required affirmative steps to ensure that the fish and fishery products you import from Italy and Spain are processed in compliance with the seafood HACCP regulations. As stated above, fish and fishery products imported from these countries are required to have product specifications as well as affirmative steps to ensure the products are processed in compliance with seafood HACCP regulations.
• Your firm does not have evidence that the fish and fishery products offered for entry into the United States have been processed under conditions that comply with the HACCP regulations. Again. as stated above, fish and fishery products imported from countries not having an active MOU with the FDA are required to have product specifications as well as affirmative steps to ensure products are processed in compliance with seafood HACCP regulations.
This is the third consecutive FDA inspection that cites your firm for not complying with the above-mentioned requirements. The previous inspections were conducted on October 2002 and May 2003. Your firm has failed to implement the necessary corrective actions to assure that the fish and fishery products being imported by your firm are safe for human consumption. Your firm has also failed to comply with the commitments made to our agency during our inspections as well as during an August 2003 meeting held at our District Office. Mr. Jose Manuel (Chema) Medina Sanchez, Vice-President for the firm. attended the meeting. During the meeting, our personnel discussed. explained, and provided information to him about the importance of the HACCP regulations concerning the public health. He was also advised of the possible consequences if your firm failed to achieve compliance.
We acknowledge the receipt of your letter dated October 14, 2005, however we find that your affirmative step is inadequate in that:
• There is no HACCP plan provided for (b)(4)
• The HACCP plan for the following foreign processors are not signed and/or dated: (b)(4) not related to any of the (b)(4) identified suppliers), (b)(4) and (b)(4)
• The HACCP plan for (b)(4) states that it was last revised 3/1/00. There is no certification that the plan has been reviewed and/or revised since 3/1/00.
• The HACCP plan for (b)(4) is not product specific, nor is it signed or dated.
You should take prompt action to correct these violations. Failure to promptly correct these violations may result in further regulatory action without notification, such as seizure. injunction, and/or detention of your future fish and fishery products without physical examination.
Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these deviations. You should include in your response documentation (e.g. copy of the affirmative step(s) taken) for our evaluation of your corrective actions. If you cannot complete all corrections within 15 working days, we expect you to explain the reasons for your delay and state when you win correct any remaining deviations.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your business operates in compliance with the Act. the seafood HACCP regulations, and the Good Manufacturing Practice regulations (21 CPR Part 110). You also have a responsibility to prevent further violations of the Act and all applicable regulations.
Please send your reply to the U.S. Food and Drug Administration, San Juan District Office, 466 Fernandez Juncos Ave., San Juan, P.R. 00901-3223, Attention: Carlos A. Medina, Compliance Officer. If you have questions regarding any issue in this letter, please contact Mr. Medina at 787-474-9538 or at email@example.com.
David Gan. M.D. Dr. PH, MPH
Acting District Director
San Juan District