Ms. Thamonwan Thawornthaweewong (Koi)
- Thaveevong Industry Co., Ltd.
206/63 Jedsadavitee Road
Mahachai, Muang Samut Sakhon
- Issuing Office:
- Center for Food Safety and Applied Nutrition
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5100 Paint Branch Parkway
College Park, MD 20742
Nov 26, 2013
VIA EXPRESS DELIVERY
Ms. Thamonwan Thawornthaweewong (Koi)
Assistant Marketing Manager
Thaveevong Industry Co., Ltd
206/63 Jedsadavitee Road
Mahachai, Muang Samut Sakhon
Samut Sakhon Thailand
Reference No. # 69453
Dear Ms. Thamonwan Thawornthaweewong (Koi):
We inspected your seafood processing facility Thaveevong Industry Co., Ltd located at 206/63 Jedsadavitee Road, Mahachai, Muang Samut Sakhon, Samut Sakhon Thailand on May 7-10, 2013. During that inspection, 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 observations found at your firm.
We acknowledge receipt of your response sent via email on May 24, 2013. Your responses included various documents including a hazard analysis and four (4) HACCP plans entitled “(b)(4),” “(b)(4),” “(b)(4),” and “(b)(4),” along with record keeping sheets, pictures of various corrective actions, various test results, and descriptions of additional corrections to the observations of concern noted on the FDA-483. However, our evaluation of the documentation revealed that the responses were 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 various cooked ready-to-eat products (i.e., covered under the four plans) are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health.
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 HACCP plans entitled “(b)(4),” “(b)(4),” “(b)(4),” and “(b)(4)” do not list the food safety hazard of Clostridium botulinum toxin formation.
These products are vacuum-packaged prior to freezing. Vacuum-packaging creates conditions conducive to Clostridium botulinum growth and toxin formation in the absence of strict temperature controls. Consequently FDA recommends each individual vacuum-package of frozen product be labeled with a “keep frozen” statement (e.g., “Important, keep frozen until used, thaw under refrigeration immediately before use”).
In addition, it is important that the vacuum-packaged product is fully frozen in a timely manner after vacuum packaging. It is not appropriate to allow vacuum-packaged product to be held at elevated temperatures for an extended time period. Our investigator observed on May 8, 2013, that your firm held the vacuum-packaged fish product at ambient temperatures of (b)(4). Holding the vacuum-packaged fish products at elevated temperatures for an extended time period creates a potential for Clostridium botulinum growth and 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 four (4) HACCP plans entitled “(b)(4),” “(b)(4),” “(b)(4),” and “(b)(4)” do not list the critical control point of cooling (i.e., following each type of cook process) for controlling the food safety hazard of pathogen growth and toxin formation.
Your cooked products receive significant handling following each type of cook step before the final packaging and freezing. Consequently, the fish products pose a risk for post-cook contamination. FDA recommends that the products be cooled to 21.1 °C within 2 hours, and then further cooled to 4.4° C within an additional 4 hours.
3. 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 HACCP plans entitled “(b)(4),” “(b)(4),” “(b)(4),” and “(b)(4)” do not list the critical control point of labeling for controlling the food safety hazard of undeclared allergens.
4. You must take an appropriate corrective action when a deviation from a critical limit occurs to comply with 21 CFR 123.7(a). However, your firm took a corrective action when your process for “(b)(4),” “(b)(4),” “(b)(4),” and “(b)(4)” deviated from your critical limit at the steaming critical control point that was not adequate to control pathogen growth and toxin formation because it did not address correcting the cause of the deviation. Although your plan lists that you will re-process the affected product, your plan does not list how you will correct the cuase that gave rise to the critical limit deviation; for example, adjusting or making repairs to the cooking equipment.
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. Your response should include documentation reflecting the changes you made, such as a copy of your revised HACCP plan or plans, five (5) consecutive days of completed monitoring records (i.e., records for the production of 5 production date codes of the products) to demonstrate implementation of the plan or plans, 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 applicable laws and regulations. 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: Sally M. Williams, 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. Sally M. Williams via email at firstname.lastname@example.org.
William A. Correll, Jr.
Office of Compliance
Center for Food Safety
and Applied Nutrition
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