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WARNING LETTER

Thai Fishsauce Factory Co., Ltd. MARCS-CMS 540119 —


Delivery Method:
Express Delivery
Product:
Food & Beverages

Recipient:
Recipient Name
Ms. Poraya Kunatien
Recipient Title
Managing Director
Thai Fishsauce Factory Co., Ltd.

21/5 - 21/7 Trok Rongnamkeng, Charoenkrung 24 Road, Taladnoi
Samphantawong, Bangkok
Bangkok 10100
Thailand

Issuing Office:
Center for Food Safety and Applied Nutrition

5001 Campus Drive
College Park, MD 20740-3835
United States


WARNING LETTER

VIA EXPRESS DELIVERY

Ms. Poraya Kunatien, Managing Director
Thai Fishsauce Factory (Squid Brand) Co., Ltd.
21/5 - 21/7 Trok Rongnamkeng, Charoenkrung 24 Road, Taladnoi
Samphantawong, Bangkok, 10100 Thailand

Reference No.# 540119

Dear Ms. Kunatien:

On August 9-10, 2017, a representative of the United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, Thai Fishsauce Factory (Squid Brand) Co., Ltd. located at 190 Moo 1 Vitarnvithee Road, Tambon Bangchakrang, Muang District, Muang Samut Songkhram, Samut Songkhram, 75000 Thailand. During that inspection, we found that you had serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulations, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). That inspection resulted in FDA's issuance of an FDA-483, lnspectional Observations, listing the deviations found at your firm at the conclusion of the inspection. We acknowledge receipt of your response received via email on August 22, 2017, which included documentation describing corrections to the observations of concern noted on the FDA-483. Upon further review of your firm's inspection report and response, we found that you continue to have violations of the seafood HACCP regulation (21 CFR 123), as further described in this letter.

In accordance with 21 CFR 123.G(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 is adulterated, in that it has been prepared, packed, or held under conditions whereby it may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and FDA's 4th Edition of the Fish and Fisheries Products Hazards & Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov. The Hazards Guide, which provides our recommendations regarding identification and control of food safety hazards reasonably likely to occur for your fish and fishery products can be found on our website at: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatorylnformation/Seafood/ucm2018426.htm

We found the following significant deviations:

1. 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 collected during the inspection for fish sauce does not list the critical control point of fish sizing of the uneviscerated fish for controlling the food safety hazard of Clostridium botulinum. Large fish (i.e., greater than 12.7 centimeters or 5 inches) pose a potential risk for Clostridium botulinum toxin formation (i.e., preformed toxin) occurring during the fermentation process for the uneviscerated fish. FDA recommends listing controls that ensure maximum fish size of the fish used to manufacture your sauce do not to exceed 12.7 centimeters (5 inches) in length from the nose and tail in order to control preformed Clostridium botulinum toxin formation.

2. 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, your firm's HACCP plan collected during the inspection for fish sauce lists inadequate critical limits at the following critical control points:

• At the Receiving critical control point, your critical limit of "(b)(4)" is not adequate to control histamine formation, Clostridium botlinum and Staphylococcus aureus growth and toxin formation. Specifically, (b)(4). Your firm needs to ensure that all the fish reach an inhibitory Water Phase Salt content of> 20% within 3 hours of death of the fish (i.e., while in transport).

• As a primary processor receiving fish directly from the harvest vessels/boats, your firm is responsible for ensuring that the fish taken from the boats are safe and were harvested and handled in a manner that prevented histamine (scombrotoxin) formation. FDA recommends that all scombrotoxin-forming fish be chilled and maintained in a chilled state on board the harvest vessels. FDA also recommends that the primary processor of scombrotoxin-forming fish either:  

•    obtain meaningful harvest vessel records, along with conducting appropriate sensory examinations and internal temperature measurements of fish upon receipt;

or

•    conduct appropriate histamine testing along with sensory examinations and internal temperature measurements of fish upon receipt. With regard to histamine levels, lots of fish that are received by the primary processor in excess of 50 ppm histamine are unacceptable for processing.

For more information, we recommend you review Chapter 7 of the Hazards Guide. 

•    At the Pasteurization critical control point, your critical limit of "(b)(4)." is not adequate to control pre-formed Clostridium botulinum toxin. FDA recommends a minimum cook temperature is 85°C for at least 5 minutes at the coldest spot in the pasteurization vessel to eliminate pre-formed toxin in finished fish sauce. Alternatively, the whole fish can undergo a rolling boil (i.e., at 100° C) for 10 minutes to eliminate pre-formed toxin.

You should respond in writing within fifteen (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, five (5) consecutive days of completed monitoring records (i.e., complete sets of monitoring records for the production of 5 date codes of products) 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. 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 fermented and pasteurized anchovy fish sauce 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)(8)). 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 the U.S. Food and Drug Administration, Attention: Philip Bermel, Compliance Officer, Food Adulteration Assessment Branch, Division of Enforcement, Office of Compliance, Center for Food Safety and Applied Nutrition, HFS-607, 5001 Campus Drive, 
College Park, MD 20740 U.S.A. You may submit documentation accompanying your reply to: philip.bermel@fda.hhs.gov. Please reference CMS# 540119 on any submissions and within the subject line of any emails to us. 

Sincerely,

/S/

William A. Correll, Jr., Director
Office of Compliance
Center for Food Safety
and Applied Nutrition