Inspections, Compliance, Enforcement, and Criminal Investigations
I.T. Foods Industries Co., LTD. 25-Jun-08
Department of Health and Human Services
Public Health Service
June 25, 2008
Mr. Sinthu Lorseethong
I.T. Foods Industries Co., Ltd.
39/108 Moo 2 Bangkrajap
Dear Mr. Lorseethong:
We inspected your seafood processing facility, located at 39/108 Moo 2 Bangkrajap, Muang, Thailand on February 14-15, 2008. Upon review of our investigator's inspection report and findings during the inspection, we determined 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 frozen steamed mackerel and frozen fresh anchovy 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 a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points, to comply with 21 CFR 123.6 (a) and (c) (2). A critical control point is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However, your firm's HACCP plan for frozen steamed mackerel and frozen fresh anchovy does not list the critical control point of "Receiving" for controlling the food safety hazard of histamine when your firm acts as a primary processor, receiving the fish directly off the harvest vessel. Histamine formation is expected to begin at the time of death because the defense mechanisms of the fish no longer inhibit the histamine forming bacteria. Histamine formation will continue if the fish are not properly handled onboard the vessels. In addition to your critical control point for receiving fish at your plant, your firm must have controls in place to assure that the fish you receive have been handled in a safe manner aboard the harvest vessel. FDA recommends implementing a combination of three controls when you receive fish directly from the harvest vessels. We recommend monitoring the internal temperatures of a representative number of fish in the lot. This should be done when the fish are unloaded from the harvest vessel so that the temperatures accurately reflect holding conditions upon the vessel. In addition, we recommend either obtaining meaningful harvest vessel records or conducting histamine testing for each lot you receive. Finally, we recommend establishing a critical limit for decomposition and conducting sensory examinations to ensure that you do not accept lots where more than 2.5% of the fish in the lot exhibit persistent odors of decomposition.
For more information related to the hazard of histamine, please refer to the Fish and Fisheries Products Hazards and Controls Guidance: Third Edition, found at: http://www.cfsan.fda.gov/~comm/haccp4.html.
You should respond in writing within thirty (30) 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 documentation in your response, such as copies of any revised HACCP plans, monitoring records for at least five (5) production days to demonstrate that you have implemented the revised plan, any verification records, and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within thirty (30) days, you should explain the reason for your delay and state when you will correct any remaining violations.
If you do not respond or if we find your response inadequate, we may take further action. 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 (DWPE). FDA's DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA's Import Alerts. For your information, we direct you to an example of an Import Alert, #16-120, that conveys information specific to foreign firms that are not in compliance with the seafood HACCP regulation (21 CFR Part 123). This alert can be found on FDA's web site at: http://www.fda.gov/ora/fiars/ora_import_ia16120.html
This letter may not list all the deviations 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: Dwayne Johnson Consumer Safety Officer, Office of Compliance, Division of Enforcement, Manufacturing and Storage Adulteration Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Dwayne Johnson by phone at (301) 436-1782 or via email at Dwayne.Johnson@fda.hhs.gov.
Acting Office Director
Office of Compliance
Center for Food Safety and Applied Nutrition