Inspections, Compliance, Enforcement, and Criminal Investigations
Thang Nguan Hah Co., Ltd. 12/03/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|College Park, MD 20740|
DEC 3, 2013
VIA EXPRESS DELIVERY
Mr. Poonsak Thangsombat
Thang Nguan Hah Co., Ltd.
253 Somdej Praya Rd.
Bangkok, Thailand 10600
Reference No. # 413779
Dear Mr. Thangsombat:
We inspected your seafood processing facility Thang Nguan Hah Co., Ltd., located at 92 Moo 1, Wat Pradoo, Amphawa, Thailand on May 9-10, 2013. During that inspection, we found that you had 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 observations made at your firm.
We acknowledge receipt of your response sent via email on May 25, 2013. Your response included a HACCP plan entitled “(b)(4). However, the response was not adequate, as further described in this letter.
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 fish sauce products are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health.
You may find the Act, the seafood HACCP regulation and the 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov. The Hazards Guide can be found on our web site at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/FishandFisheriesProductsHazardsandControlsGuide/default.htm
Your significant deviations are as follows:
1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that 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 firm’s HACCP plan for (b)(4) does not identify the food safety hazards of undeclared allergens and pathogen growth/toxin formation, specifically Clostridium botulinum and Staphylococcus aureus toxin formation.
2. 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 revised HACCP plan for (b)(4) does not list critical control points to control exposure temperatures during processing for histamine forming fish species, such as anchovies to control the hazard of histamine.
Your firm was observed storing and handling fish at ambient temperatures (i.e., unrefrigerated) from the time of receipt to the start of the fermentation process. However, your revised HACCP plan for (b)(4) only includes critical control points for receiving and fermenting. Your firm may choose to combine all the processing steps into a single critical control point that captures all the cumulative time and temperature exposures at unrefrigerated temperatures throughout your entire process; or your firm may choose to include multiple critical control points to address each individual step when the fish are exposed to unrefrigerated temperatures. In any event, all the cumulative time exposures will need to be addressed in the plan.
3. 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, at the “Receiving” critical control point your revised HACCP plan for Fish Sauce lists critical limits that are not adequate, as follows:
a. The critical limits are not adequate to control histamine formation.
With regard to histamine testing, your firm’s plan lists a critical limit of “(b)(4)” and the plan appears to indicate that your firm is (b)(4). FDA recommends a critical limit for histamine be reduced when compositing samples. For example, we recommend a critical limit of < 17 ppm when a firm composites 3 fish into a single sample; or < 8.3 ppm when a firm composites samples of 6 fish into a single sample.
With regard to internal temperature monitoring of the fish, your plan lists “(b)(4).” However, the plan does not include any temperature controls. For fish that are in transit from the wharf to the facility, time alone is not adequate to control histamine formation. In addition to controlling transport times, processors should also ensure that the fish were adequately chilled throughout the transport time period.
In addition to monitoring time and temperature when the fish are received at your processing facility, FDA also recommends that your firm, as the primary processor (i.e., the first processor to receive the fish after unloading from the vessels), conduct monitoring of the internal temperatures of the fish at the time they are offloaded from the harvest vessel to ensure that fish were properly chilled after capture and while held onboard the harvest vessels.
b. The critical limits are not adequate to control decomposition in histamine- forming fish.
Although your plan lists that “(b)(4),” the plan does not define what amount of decomposition will result in the lot being rejected. Currently, FDA recommends that firms establish a minimum critical limit of “less than 2.5%” for the presence of decomposition in a lot.
Additionally, your firm’s plan lists that you will (b)(4)” for signs of decomposition. FDA recommends performing sensory examination of a minimum of 118 fish per lot.
4. 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 revised HACCP plan for (b)(4) lists a monitoring frequency at “Receiving” critical control point is not adequate to monitor histamine levels.
Specifically, your plan lists “(b)(4).” FDA recommends that processors collect 18 representative 1 pound subsamples (i.e., multiple fish for smaller species) from each vessel lot. Each vessel should be considered a separate lot for sampling. Further, the incoming lots should be clearly defined, and sampling should be scaled to match lot size to ensure sampling is representative (i.e., more samples for a larger shipment) for each harvest vessel.
5. You must take appropriate corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(b). However, your corrective action plans at the “Receiving” critical control point are not adequate to control histamine. Your plan states “(b)(4).” FDA recommends rejecting the lot and discontinuing the use of the supplier until evidence of corrections to the root cause of the deviation has been provided.
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these deviations. More specifically, your response should include documentation reflecting the changes you made, such as a copy of your revised HACCP plan or plans for fish sauce, five (5) consecutive days of completed monitoring records to demonstrate implementation of the plan, and any additional information that you wish to supply that provides assurance of your intent to fully comply now and in the future with the seafood HACCP regulation. In addition, please provide your firm’s process flow for fish sauce production as well as monitoring and verification records for histamine analysis. Submission of the information in English will assist in our review. If you cannot complete all corrections within 15 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, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the seafood HACCP regulation is Import Alert #16-120. You may view this alert at: http://www.accessdata.fda.gov/cms_ia/ialist.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 and all applicable regulations, including the Seafood HACCP regulation, and the Good Manufacturing Practice regulation (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Additionally, Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. § 379j-31(a)(2)(B)). For a foreign facility, FDA will assess and collect fees for re-inspection-related costs from the U.S. Agent for the foreign facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs. Please consider providing a copy of this letter to your U.S. Agent.
Please send your reply to Food and Drug Administration, Attention: Mildred Benjamin, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Food Adulteration Assessment 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 Ms. Benjamin via email at: firstname.lastname@example.org.
William A. Correll, Jr.
Office of Compliance
Center for Food Safety
and Applied Nutrition