Inspections, Compliance, Enforcement, and Criminal Investigations
Del Mar Seafood Inc 02-May-06
Department of Health and Human Services
Public Health Service
555 Winderley PI., Ste. 200
RETURN RECEIPT REQUEST
May 2, 2006
Maria S . Martinez-Robaina, President
Del Mar Seafood Inc.
Post Office Box 226405
Miami, FL 33122-6405
Dear Mrs. Martinez-Robaina:
We inspected your seafood importer establishment, located at 5900 NW 97th Avenue, Unit 17b, Miami, Florida 33178 on April 10-12, 2006. We found that you have a serious violation of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123). 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 Part 123. If assurances do not exist that the imported fish or fishery product has been processed under conditions that are 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 Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4) and will be denied entry. Because our inspection identified a serious violation for 21 CFR Part 123, your fresh mahi-mahi is adulterated under Section 402(a)(4)of the Act (21 U.S.C. § 342(a)(4)), 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 is as follows:
1. You must implement an affirmative step which ensures that the fish and fishery product(s) you import are processed in accordance with the seafood HACCP regulation, to comply with 21 CFR 123.12(a)(2)(ii). However, your firm performed an affirmative step for fresh mahi-mahi imported from [redacted] that is not adequate. Specifically, your firm failed to obtain an adequate written guarantee from the firm. Your verification procedures require the firm provide a written guarantee. However your certification form appears to record that your firm certifies the foreign processor adheres to the requirements of HACCP and is not actually a written guarantee from the foreign processor.
We may take further action if you do not promptly correct this violation. 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 all these violations. You should include in your response documentation, such as HACCP and importer verification records and records that document the performance and results of your firm's affirmative steps, 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.
Please send your reply to the Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida 32751, Attention: Shari H. Shambaugh. If you have questions regarding any issues in this letter, please contact Ms . Shambaugh at 407-475-4730.
Emma R. Singleton
Director, Florida District