Mr. Paramesawa Sornsong
- Natural Sea Product Co., Ltd.
29/6, Moo 3; Tambol Bangyapak
Muang Samut Sakhon, Samut Sakhon
- Issuing Office:
- Center for Food Safety and Applied Nutrition
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5001 Campus Drive
College Park, MD 20740
SEPT 4, 2018
VIA EXPRESS DELIVERY
Mr. Paramesawa Sornsong, Managing Director/Owner
Natural Sea Product Co., Ltd.
29/6, Moo 3; Tambol Bangyapak
Muang Samut Sakhon, Samut Sakhon, 74000
Reference # 562272
Dear Mr. Paramesawa Sornsong:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, Natural Sea Product Co., Ltd., located at 29/6, Moo 3; Tambol Bangyapak, Muang Samut Sakhon, Samut Sakhon, Samut Sakhon, 74000, Thailand on May 8 and 9, 2018. That inspection revealed serious violations of 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 FDA’s issuance of an FDA-483, Inspectional Observations, listing the deviations found at your firm at the conclusion of the inspection. We acknowledge receipt of your response received via email on May 22, 2018, which included a cover letter outlining your corrective actions, a revised HACCP plan entitled “Dried Fish” that covers your shelf-stable, vacuum-packaged dried fish products, and photos of corrective actions made to the facility. Review of the documentation revealed that your response is not adequate, as further described in this letter.
In accordance with 21 CFR 123.6(g), failure of a seafood processing facility 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 shelf-stable, vacuum-packaged dried fish 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 Fishery Products Hazards and Controls Guidance (the Hazards Guide) through links on 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 web site at: http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/seafood/ucm2018426.htm
We found the following significant deviations:
1. You must conduct or have conducted 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 revised HACCP plan provided with your May 22, 2018, email entitled “Dried Fish” does not list the food safety hazard of natural toxins (e.g., ciguatera toxin), which is reasonably likely to occur in yellow stripe trevally caught in tropical and subtropical waters that your firm needs to control as the primary processor receiving the fish directly from the harvest vessels.
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 (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 revised HACCP plan entitled “Dried Fish” does not list the following CCPs that are necessary to control each of the identified food safety hazards. Specifically,
a. A (b)(4) CCP that is necessary to control the food safety hazard of scombrotoxin (histamine) formation, which is reasonably likely to occur in your dried scombroid species fish while held (b)(4). FDA recommends you include a refrigerated storage CCP to ensure that products held for extended time periods in-process are stored continuously at a temperature of 4.4° C or below or completely and continuously surrounded by ice throughout the storage period.
b. A (b)(4) critical control point to control the food safety hazards of scombrotoxin (histamine) formation and pathogenic bacteria growth and toxin formation. FDA recommends you include salting and curing CCPs to ensure that the fish are held at appropriate temperatures to prevent the hazards of scombrotoxin (histamine) formation and pathogen growth and toxin formation (i.e., including the potential for growth and toxin formation from the salt tolerant Staphylococcus aureus (S. aureus) organism identified in your HACCP plan). FDA recommends that the fish are continuously held at 4.4° C or below for the entire duration of the salting/curing step.
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, your firm’s revised HACCP plan provided with your May 22, 2018, email for “Dried Fish” lists critical limits that are not adequate to control S. aureus growth and toxin formation and scombrotoxin (histamine) formation. Specifically, at the “(b)(4)” critical control point your critical limit of “(b)(4)” alone is not adequate to control the identified food safety hazards. FDA recommends that you also include corresponding critical limits for time or temperature or a combination of both at this step to prevent the formation of scombrotoxin (histamine) and S. aureus until a safe water activity (0.85> However, we note that your monitoring procedures at this “(b)(4)” CCP list processing temperatures of (b)(4) – (b)(4)°C. Although (b)(4)°C is sufficient to control S. aureus growth/toxin formation, it is inadequate to control scombrotoxin (histamine) formation for the duration of the (b)(4) step. FDA recommends temperatures of 60°C or higher to inhibit/prevent histamine formation during extended drying/dehydration time periods when there is no critical limit for time. At your current processing temperatures of (b)(4) – (b)(4) °C, FDA recommends that you establish through a scientific study, the processing parameters that will allow the fish flesh to achieve a water activity of 0.85 or less within 3 hours. Additionally, the drying temperatures currently listed in your monitoring procedures should be listed as critical limits if they are critical drying factors. This would also apply to any critical limits for time that you establish as critical to the drying. In addition, our investigation revealed that your firm is monitoring the moisture conditions in the solar dome. If this is a critical factor, you should consider establishing a critical limit for moisture (relative humidity).
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. More specifically, your response should include documentation and information that would assist us in evaluating your corrections, such as 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 you have complied with FDA regulations, 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. This alert can be found on FDA’s web site at: http://www.accessdata.fda.gov/cms_ia/importalert_25.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 and the current Good Manufacturing Practice Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (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.
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 the Food and Drug Administration, Attention: Marco Esteves, Compliance Officer, Office of Compliance, Division of Enforcement, 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Marco Esteves via email at email@example.com
. Please reference #CMS 562272 on any submissions and within the subject line of any emails to us.
William A. Correll, Jr.
Office of Compliance
Center for Food Safety
and Applied Nutrition