| Public Health Service Food and Drug Administration |
| Chicago District 550 West Jackson Blvd., 15th Floor Chicago, Illinois 60661 Telephone: 312-353-5863 |
Department of Health and Human ServicesJanuary 13, 2010
WARNING LETTER
CHI-03-10
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Mr. Van Giragosian
President
Gold Star Seafood, Inc.
2300 West 41st Street
Chicago, Illinois 60609-22 I4
Dear Mr. Giragosian:
We inspected your seafood processing facility, located at 2300 West 41st Street, Chicago, Illinois, on August 26, 28, 2009 and September 01 & 10, 2009. 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 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 pasteurized, refrigerated ready-to-eat canned crab meat products are adulterated, in that they've 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, 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 occurrence of the identified food safety hazard." However your firm's HACCP plan for "Pasteurized crab meat in hermetically sealed steel cans" lists a critical temperature limit at both the receiving and storage critical control points that is inadequate to control pathogen growth. Your plan lists a temperature of (b)(4) however, ready to eat pasteurized crab meat should be continuously maintained at or below 40°F to prevent pathogen growth and potential toxin formation, including Clostridium botulinum growth and toxin formation.
» You must have a HACCP plan that, at a minimum lists the monitoring procedures and their frequencies for each critical control, to comply with 21 CFR 123.6(c)(4). However, your firm's HACCP plan for "Pasteurized crab meat in hermetically sealed steel cans" lists monitoring procedures/frequencies at the receiving and storage critical control points that are not adequate to control pathogen growth and potential toxin formation, including Clostridium botulinum growth and toxin formation.
• Your monitoring procedure at the receiving critical control point is inadequate because taking a one time temperature of the truck, as listed in your plan, will not provide any information concerning the temperatures during the transit period to your facility. Your plan should include a method of monitoring and recording temperatures on a continuous basis during the entire transit period, to ensure that unsafe temperature fluctuations do not occur over extended time periods. This is particularly important because it was revealed during our inspection that product is held on the trucks, at delivery, for extended periods of time prior to being unloaded.
• Your monitoring procedure at the storage critical control point is inadequate because monitoring the temperature (b)(4) times per day as listed in your plan provides no information concerning the temperatures of the cooler between those three checks per day. Moreover, this monitoring frequency is inadequate for implementing your critical limit during storage which lists that temperatures not exceed the listed limit for more than 2 hours. Checking (b)(4) per day, over a (b)(4) hour period will have time gaps of longer than 2 hours. We suggest that in order to ensure that cooler temperatures are properly and consistently maintained that firms use monitoring equipment capable of monitoring and recording cooler storage temperatures on a 24 hour a day/7 day a week basis. We also suggest a daily check of the temperature records and of the equipment.
(b)(3)(A)
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 in violation of Section 402(a)(4) of the Act (21 U.S.C. §342 (a)(4) and the seafood HAACP regulation.
(b)(3)(A)
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: Rosemary Sexton, Compliance Officer, at the address above. If you have any questions regarding any issues in this letter, please contact Ms. Sexton at 312-596-4225.
Sincerely,
/s/
Scott J. MacIntire
District Director
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