DEPARTMENT OF HEALTH & HUMAN SERVICES
March 19, 2012
VIA E-mail – PDF copy
VIA OVERNIGHT DELIVERY (original)
Mr. Wichion Bumrueruk,
I.T Foods Industries Co. Ltd.,
39/108 MOO 2 Bangkrajao
Muang, Samut Sakhon,
Reference No.: 281558
Dear Mr. Bumrueruk:
On September 12 and 13, 2011, the U.S. Food and Drug Administration (FDA) conducted an inspection of your fresh frozen fish and shrimp and dried frozen fish product manufacturing facility, I.T. Foods Industries Co. Ltd., located at 39/108 MOO 2 Bangkrajao, Muang, Muang Samut Sakhon. We found that you had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of federal Regulations, Part 123 (21 CFR 123). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations, listing the deviations found at your firm.
Failure of a processor to have and implement a HACCP plan that complies with 21 CFR 123.6(g), or otherwise in accordance with the requirements of 21 CFR part 123, renders the 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 firm’s fishery products appear to be adulterated, in that the products have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act and the Seafood HACCP regulation through links in FDA’s home page at www.fda.gov. The Seafood HACCP guide is on FDA’s website at:
We acknowledge receipt of your February 13, 2012, response that provided revised HACCP plans, training materials, and records to address observations of concern noted on the FDA-483 issued at the conclusion of the inspection. Our review revealed that the response was not adequate, as described below.
We note the following serious deviation from the requirements of the Seafood HACCP regulation:
Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan for frozen fresh anchovies and frozen steamed mackerel at the receiving critical control point to control histamine formation is not appropriate.
Your HACCP plan lists as your critical limits and monitoring procedures in your plan, that your firm is monitoring presence of ice at receipt; however, your corrective actions include evaluation of total time and temperature exposures. Your firm will not have any time or temperature parameters on which to base an evaluation, because you are only monitoring the presence of adequate ice. FDA recommends, as appropriate corrective actions, rejecting the lot or diverting to a non-food use or chilling and holding the affected lot until histamine analysis can be performed and then performing histamine testing on a minimum of 60 fish representatively collected from throughout the lot, including any fish measured to have temperatures that exceed the critical limit (or the entire lot for lots smaller than 60 fish).
In addition we noted in your flow diagram for frozen fish that you glaze the fish prior to weighing it. It is important to note that the weight of the glaze cannot be part of the net weight declared on the label and it is necessary to weigh the fish prior to glazing.
We note also, that at this time your firm’s products are subject to detention without physical examination (i.e., DWPE) via Import Alert #16-81 "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella." FDA recommends that your firm determine the source of the salmonella and implement control strategies and sanitation operating procedures (SOPs) to prevent contamination of your fish and fishery products with this pathogen.
This letter may not list all the violations at your facility. You are responsible for ensuring that your firm operates in compliance with the Act and the fish and fishery products regulations (21 CFR Parts 123). You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.
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 in your response documentation 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.
Please send your reply to the U. S. Food and Drug Administration, Attention: Carol D’lima, Office of Compliance, Division of Enforcement, Food Assessment Adulteration Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding any issue in this letter, you may contact Ms. D’lima at (240) 402-2033 or via email at Carol.Dlima@fda.hhs.gov.
Division of Enforcement
Office of Compliance
Center for Food Safety
and Applied Nutrition