WARNING LETTER
Sakhon Wattana Thang Chue Hah
MARCS-CMS 684767 —
June 25, 2024
Delivery Method:
Via Express Delivery and Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Polapark Thanyodom
Recipient Title
Managing Director
Sakhon Wattana Thang Chue Hah
10 Khor, Thammakunakorn Rd.
Krokkrak
,
Mueang Samut Sakhon
Samut Sakhon
74000
Thailand
sakhonwattana999@gmail.com
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
WARNING LETTER
June 25, 2024
Reference # 684767
Dear Mr. Polapark Thanyodom:
The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, Sakhon Wattana (Thang Chue Hah), located at 10 Khor, Thammakunakorn Rd., Krokkrak, Mueang Samut Sakhon, Samut Sakhon, Thailand 74000, on February 13 - 14, 2024. During the 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 (21 CFR Part 123). We acknowledge receipt of your response received via email on February 27, 2024, which included a copy of a research document titled “Study of contamination by
Clostridium Botulinum
and disease-causing microorganisms in the fish sauce production process” dated 2014 by the Thai Fish Inspection and Quality Control Division, Department of Fisheries, and description of corrections your firm has taken. However, our evaluation of the document revealed that you continue to have serious concerns with your HACCP program 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 ready-to-eat fish sauce made from fermented, salted, uneviscerated anchovies 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 the June 2022 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.
Your significant deviations are as follows:
1. You must conduct or have conducted a hazard analysis for your ready-to-eat fish sauce made from fermented, salted, uneviscerated anchovies 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 does not list the food safety hazards of
Clostridium botulinum
and toxin formation which is reasonably likely to occur during processing of salted raw uneviscerated fish and
Staphylococcus
aureus
growth and toxin formation which is reasonably likely to occur after the salting of the fish in the absence of controls.
2. You must have a HACCP plan for your ready-to-eat fish sauce made from fermented, salted, uneviscerated anchovies that at 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 “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. As a secondary processor, your firm receives fish from a supplier who receives fresh fish from the harvest vessels. The supplier mixes the fresh fish with salt and then transports them to your firm. However, the critical limits listed at the
(b)(4)
step CCP1 of your HACCP plan are inadequate to control the hazard of histamine. Specifically,
a. The HACCP plan lists a critical limit for the pre-
(b)(4)
ratio as
(b)(4)
at processing step
(b)(4)
(
(b)(4)
) but does not list a critical limit identifying a minimum water activity (Aw) or water phase salt (WPS) for the
(b)(4)
at the
(b)(4)
CCP1. The salt-to-fish critical limit is supported by a study and the plan lists procedures for monitoring the salt to fish ratio; however, the plan must also identify the targeted Aw or WPS.
b. The temperature critical limits of
(b)(4)
°C and
(b)(4)
°C listed at
(b)(4)
CCP1 are inadequate to prevent histamine formation. In addition, the plan does not describe if these limits are internal temperatures or refrigeration temperatures.
3. You must have and implement monitoring procedures and frequency that will be used to monitor each of the critical control points, to comply with 21 CFR 123.6(b) and (c)(4).
However, your firm’s HACCP plan does not list monitoring procedures for monitoring temperature critical limits of
(b)(4)
°C and
(b)(4)
°C at the
(b)(4)
CCP1. The receiving monitoring record shows a single temperature reading which is inadequate. FDA recommends monitoring the adequacy of ice or monitoring ambient refrigeration temperatures with a continuous monitoring device.
4. Since you chose to include corrective actions in your HACCP plan for your ready-to-eat fish sauce made from fermented, salted, uneviscerated anchovies, your corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective actions at the
(b)(4)
and fish sauce storage critical control points are not adequate to ensure that affected product has not entered commerce and that the cause of the deviation was corrected as required by 21 CFR 123.7(b). Specifically, your corrective action listed at the
(b)(4)
raw materials CCP2 lists “
(b)(4)
” does not list controls that address correcting the cause of the critical limit deviations.
Moreover, our investigator observed that your firm rinses their food contact surfaces with a
(b)(4)
ppm chlorine solution. You do not wash the surfaces to avoid any soap or sanitizer residues. We acknowledge your concerns; however, 21 CFR 117.35(d) requires that food contact surfaces are cleaned and sanitized, a four-step process. It requires rinsing the work surface to remove particulate filth or residues, washing the surface to remove any remaining particulate filth; rinsing to remove soap, particulates, and residues; and finally sanitizing those surfaces to eliminate environmental pathogens. Even though pathogens are not a safety concern due to the Aw or WPS in the finished product, the introduction of unintended particulate residues leftover from previous operations renders the seafood product adulterated under Section 402(a)(4) of the FD&CA.
For additional guidance you may reference the
Fish and Fishery Products Hazards & Controls Guidance
- June 2022 Edition at https://www.fda.gov/media/80637/download, Chapter 7 Scombrotoxin (Histamine) Formation; Chapter 12: Pathogenic Bacteria Growth and Toxin Formation (Other than
Clostridium botulinum
) as a Result of Time and Temperature Abuse; Chapter 13 for
Clostridium botulinum
Toxin Formation; and Chapter 14 Pathogenic Bacteria Growth and Toxin Formation as a Result of Inadequate Drying.
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 production 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 believe that your product is not in violation of the Act, include your reasoning and any supporting information for our consideration.
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 Current Good Manufacturing Practice regulation (21 CFR Part 117, Subpart B). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
You should direct your written reply to Giselle Jordan, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions regarding this letter, you may contact Giselle Jordan via email at Giselle.jordan@fda.hhs.gov. Pease reference CMS #684767 on any submissions and on the subject line of any emails to us.
Sincerely,
/S/
Ann M. Oxenham, J.D.
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
07/09/2024
Regulated Product(s)
Food & Beverages