Inspections, Compliance, Enforcement, and Criminal Investigations
Blessing Inc. (DBA Blessing Seafood) 09-Oct-08
Department of Health and Human Services
Public Health Service
Southwest Import District
October 09, 2008
Via Federal Express
Blessing Inc. (DBA Blessing Seafood)
David Mayorquin, President
1045 S. Highland Avenue
Tucson, AZ 85719
Dear Mr. Mayorquin:
We inspected your seafood importer establishment, located at 1045 S. Highland Avenue, Tucson, AZ 85719 on September 05, 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 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 serious violations for 21 CFR Part 123, your Scombrotoxin forming fish (i.e. mackerel and yellowtail) are adulterated under Section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4)), 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 homepage at www.fda.gov.
Your significant violations were as follows:
You do not have or have not implemented written verification procedures for ensuring that fish you import are processed in compliance with the Seafood HACCP regulation. The written verification procedures shag list, at a minimum: (1) product specifications designed to ensure that the product is not adulterated under the Act because it may be injurious to health or have been processed under insanitary conditions; and (2) affirmative steps. 21 CFR 123.12(a)(2).
Specifically, your firm does not have written product specifications or affirmative steps for Scombrotoxin producing fish (i.e., mackerel & yellowtail), as required by 21 CFR 123.12(a)(2)(i) &(ii).
Your firm must properly implement written affirmative steps to ensure that the fish and fishery product(s) that you import are processed in accordance with the seafood HACCP regulation, as required by 21 CFR 123.12 (a)(2)(i) & (ii).
Lastly, you have failed to maintain records that document the performance and results of affirmative steps, as required by 21 CFR 123.12(c) and 123.9.
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 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, Attention: Lisa M. Puttonen, Compliance Officer, Southwest Import District, 4040 North Central Expressway, Dallas, Texas, 75204. If you have questions regarding any issues in this letter, please contact Ms. Puttonen at 214-253-5285.
Robert J. Deininger
Southwest Import District