Inspections, Compliance, Enforcement, and Criminal Investigations
George's Fish and Seafood 27-Jun-07
Department of Health and Human Services
Public Health Service
June 27, 2007
RETURN RECEIPT REQUESTED
Jessie D. George, Owner
George's Fish & Seafood
P.O. Box 720
Marvell, Arkansas 72366
Dear Mr. George:
We inspected your seafood processing facility, located at 15646 Highway 149 Marvell, Arkansas on February 24, March 2 and 9, 2007. 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, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). 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 paddlefish and sturgeon roe products 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 violations were as follows:
• You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm's HACCP plan for paddlefish and sturgeon roe does not list a critical limit of "Temperature" at the "Receiving" critical control point to control pathogen and toxin formation.
• You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and(c)(4). However, your firm did not follow the monitoring procedure and frequency of "continuous monitoring" using a "temperature indicating and recording device" at the "Finished Product Refrigerated Cold Storage" critical control point to control pathogen growth and toxin formation listed in your HACCP plan for paddlefish and sturgeon roe. Your firm has no equipment capable of continuously monitoring storage temperature. In addition, we suggest daily monitoring of equipment and charts, which is not currently part of your HACCP plan.
During the inspection, you stated that your firm receives and further distributes into interstate commerce both labeled and unlabeled paddlefish roe products. In addition to the above deviations from the seafood HACCP regulation, your paddlefish roe products are misbranded within the meaning of section 403 of the Act [21 U.S.C. 343], as follows:
• The unlabeled paddlefish roe products you receive and further distribute unlabeled into interstate commerce are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. §343(e)(1)], as well as 21 CFR 101.5(a), in that the package labels do not specify the place of business of the manufacturer, packer, or distributor.
• Further, your unlabeled paddlefish roe products are further misbranded under sections 403(i)(1) and (2) [21 U.S.C. §343(i)(1) and (2)] of the Act, in that they do not list the common or usual name of the food nor each of the ingredients in the product, in accordance with 21 CFR 101.3(a) and 101.4(a)(1), respectively.
Your unlabeled paddlefish roe products and your product George's Fish & Seafood Paddlefish Caviar are misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] in that they do not declare the net quantity of contents, as set forth in 21 CFR 101.105.
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 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.
Please send your reply to the Food and Drug Administration, Attention: Sherrie L. Krolczyk, Compliance Officer, at the above letterhead address. If you have any questions regarding any issue in the letter, please contact Sherrie L. Krolczyk at(214) 253-5312.
A. Blake Bevill
Acting Dallas District Director