DEPARTMENT OF HEALTH & HUMAN SERVICES
March 23, 2012
VIA OVERNIGHT DELIVERY
Mr. Voravee Eang-Chuan
Southeast Asian Packaging and Canning Ltd.
Bangapoo Industrial Center, Sukhumvit Rd,
Praksa District, Amphur Muang,
Reference No.: 276096
Dear Mr. Eang-Chuan:
We inspected your seafood processing facility, Southeast Asian Packaging and Canning Ltd., located at 233 Moo 4, Bangapoo Industrial Center, Sukhumvit Rd, Praksa District, Amphur Muang, Samutprakarn, Thailand, on September 5 and 6, 2011. During that inspection, we found that you had serious deviations from the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). That inspection resulted in and FDA-483, Inspectional Observations, listing the deviations found at your firm at the conclusion of the inspection.
Accordingly your tuna in hermetically sealed pouches 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 and the Seafood HACCP regulation through links in FDA’s home page at www.fda.gov.
We acknowledge receipt of your October 7, 2011, response that provided various documents, including revised HACCP plans and pictures of changes that were made 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 deviations from the requirements of the Seafood HACCP regulation:
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 (CCP) 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 pouch packed tuna does not list the critical control point of thawing until the start of precooking to control histamine formation. Histamine formation results from exposure of the fish to temperatures b(4) Acceptable cumulative times depend on whether the fish are fresh or previously frozen, and if the pre-cook process will be sufficient to control histamine. Your firm should also evaluate whether your precooking process will effectively inhibit histamine formation in the post-precooking processing steps. This will directly affect the critical limit you establish for exposure times.
You must conduct a hazard analysis for each kind of fish and fishery product you produce 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 food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3 (f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your HACCP plan for pouch packed tuna fails to identify the food safety hazard of Staphylococcus aureus growth and toxin formation. The handling of the fish after the cooling process (i.e. heading, skinning, cleaning, packing, staging for retorting) introduces the hazard and time/temperature exposures must be controlled during these steps. FDA recommends that the time period from the precook to retorting be limited to 3 hours.
You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point to comply with 21 CFR 123.6(c)(4). However, your firm’s HACCP plan for tuna in a pouch does not list a monitoring frequency for the critical limits of decomposition or internal temperature at the Receiving critical control point. The number of samples necessary to make a judgment about a lot should not be b(4) the sampling should be representative. FDA recommends that the internal temperature should be 4.4°C or below.
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 tuna in a pouch at the Receiving CCP had the following inadequate corrective actions:
For histamine testing, your plan states that the lot will be “rechecked.” If you plan to do this as a corrective action, your firm should use saved portions of the previous samples to retest to determine if the levels exceed 50 ppm in the single fish samples, and not collect new samples from the same lot.
For histamine testing, your plan does not address what will happen to the lots or how the lots’ integrity will be maintained prior to the outcome of retesting.
FDA recommends that when the sensory evaluation fails to meet the critical limits on initial sampling, that firms then conduct sensory evaluation on 100% of the fish in the lot.
For internal temperature, in addition to what you have listed, FDA recommends that firms conduct histamine testing on a representative sample of 60 fish in the lot when initial sensory evaluation fails to meet the critical limits.
If any of your critical limits are exceeded, your plan should provide controls that address the source of the fish and the harvest vessels.
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