Inspections, Compliance, Enforcement, and Criminal Investigations
Hana Gourmet, Inc. dba Beyond Gourmet 10/16/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
October 16, 2012
Marwan R. Saboune, Owner
Hana Gourmet, Inc.
dba Beyond Gourmet
9211 Diplomacy Row
Dallas, TX 75247
Dear Mr. Saboune:
We inspected your seafood processing facility, located at 9211 Diplomacy Row, Dallas, TX, 75247, on July 5 - 9, 2012. 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 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 refrigerated marinated anchovy fillets 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.
Your significant violation was 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 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 for refrigerated marinated anchovy fillets to control the food safety hazards of pathogen growth and toxin production, or scombrotoxin (histamine). Anchovies are a scombroid species of fish, and therefore, pose a reasonably likely hazard for scombrotoxin (histamine) formation.
Further, you do not control the hazards of pathogens and histamine, in that you do not ensure that the anchovies have been appropriately refrigerated throughout transportation, and you do not have continuous temperature monitoring of your cooler where the anchovies are stored.
We acknowledge receipt of your response letter, sent via email on September 7, 2012. The letter states that the anchovy fillets were ordered in error, your manager did not realize that the product needed refrigeration, and that you will not carry refrigerated seafood products anymore. However, the investigator observed the same brand and type of anchovy products at your facility during the previous inspection conducted on October 2- November 9, 2010, and discussed the product's refrigeration requirements with you at that time.
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.
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.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including re-inspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting there-inspection fees (21 U.S.C. 379j-31 (a)(2)(B)).
For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
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.
Please send your reply to the U.S. Food and Drug Administration, Attention: Seri L. Essary, Compliance Officer, at the above letterhead address. If you have questions regarding any issues in this letter, please contact Seri L. Essary at (214)253-5335.
Reynaldo R. Rodriguez, Jr.
Dallas District Director