- Delivery Method:
- Via Express Delivery
- Food & Beverages
Recipient NameMs. Kim Ngan Ong
Recipient TitleVice Director
- Thanh Ha Fish Sauce Co.
Lot C, 42B/1 Street No. 7, Vinh Loc IP, Binh Chanh Dist
Ho Chi Minh
Binh Dinh Province 70000
- Issuing Office:
- Center for Food Safety and Applied Nutrition (CFSAN)
5001 Campus Drive
College Park, MD 20740
FEB 28, 2017
Dear Ms. Ong:
The U.S. Food and Drug Administration (FDA) inspected your fermented fish sauce manufacturer, Thanh Ha Fish Sauce Co. located at KP5-Duong Dong Town, Phu Quoc Island, Kien Giang Province Vietnam on September 5 and 6, 2016. During this inspection, we found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). This 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. To date, we have not received a response to the FDA-483.
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 anchovy 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 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 4th Edition of the Hazards Guide can be found on our web site at: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatorylnformation/Seafood/ucm2018426.htm.
We note the following significant deviations:
1. You must have a HACCP plan that lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR123.6(c)(1). However, your firm's HACCP plan for Anchovy Fish Sauce does not list the food safety hazard of Clostridium botulinum (C. botulinum) toxin formation.
Specifically, our investigator observed that your process uses uneviscerated fish as a raw material. C. botulinum spores are known to be present in the viscera of fish and may grow and produce toxin due to the anaerobic environment within the body cavity when the fish are exposed to unchilled/unrefrigerated conditions. To prevent toxin from developing during processing and to eliminate any pre-formed C. botulinum toxin in uneviscerated fermented fish products, FDA recommends that processors include critical control points in their HACCP plan to (1) eliminate pre-formed toxin, (2) prevent toxin formation during processing and (3) ensure shelf stable products such as your sauces reach a water phase salt level of 20% or more; or reach a water activity level of 0.85 or less under conditions that will prevent toxin formation. For more information regarding the hazard of C. botulinum, please refer to Chapter 13 of FDA's Fish and Fishery Products Hazards and Controls Guidance: 4th Edition, at: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatorylnformation/Seafood/ucm2018426.htm
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 for Anchovy Fish Sauce does not list a critical limit at Receiving Salted Fish critical control point that is adequate to control scombrotoxin (histamine) formation.
Specifically, the critical limit section is blank for your HACCP plan at the "Receiving Salted Fish" critical control point. Your firm receives the fish directly from the fishing vessels, where scombrotoxin (histamine) formation is possible during handling operations on board the vessels, including during the salting operation which appears to be conducted on board the fishing vessel and is reasonably likely to occur until the fish reach a water phase salt or water activity level adequate to prevent histamine formation (i.e. at least 20% water phase salt or water activity of 0.85 or less). Your receiving critical control point needs to include critical limits for histamine testing, sensory examination and water phase salt measurements. In addition, your HACCP plan should list appropriate monitoring procedures to ensure the appropriate critical limits are met.
For more information regarding the hazard of scombrotoxin (histamine) formation please refer to Chapter 7 of FDA's Fish and Fishery Products Hazards and Controls Guidance: 4th Edition, at: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatorylnformation/Seafood/ucm2018426.htm
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 that would assist us in evaluating your corrections, such as a copy of any revised HACCP plans; at least five (5) consecutive days of completed monitoring records to demonstrate that you have implemented the revised plan or plans; any verification records; and any other useful information. 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 (21 CFR Part 123) is Import Alert #16-120. This alert can be found on FDA's web site at: http://www.accessdata.fda.gov/cms_ia/importalert25.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 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 the Food and Drug Administration, Attention: Nicholas Long, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch (HFS-607), 5001 Campus Drive, College Park, MD 20740, U.S.A. If you have any questions regarding this letter, you may contact Mr. Long via email at Nicholas.Long@fda.hhs.gov. Please reference# 515037 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