Inspections, Compliance, Enforcement, and Criminal Investigations
Tang Sang Hah Co., Ltd 3/21/14
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|5100 Paint Branch Parkway|
College Park, MD 20740
VIA EXPRESS DELIVERY
Mar 21 2014
Mr. Worachet Pongpairoj, Managing Director
Tang Sang Hah Co., Ltd.
197 Moo 4 Sukumvit Road
Samutprakarn 10280 Thailand
Reference No.# 414360
Dear Mr. Pongpairoj:
The U.S. Food and Drug Administration obtained a copy of your firm's seafood HACCP documentation for your fermented fish sauce product during a recent inspection of your facility. Our evaluation of your firm's HACCP plan for fermented fish sauce entitled "Pairoj (Tang Sang Hah) Co., Ltd. ," collected during the inspection, revealed deviations from FDA's Seafood HACCP requirements, as 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 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 the 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. 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/GuidanceComplianceRegulatorylnformation/GuidanceDocuments/Seafood/FishandFisheriesProductsHazardsandControlsGuide/default.htm
Your significant deviations are as follows:
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 for (b)(4) does not list critical control points to control your identified hazards of Clostridium botulinum toxin formation and histamine.
Your firm should identify your receiving step as a critical control histamine formation. Our investigation revealed that the fish are (b)(4). Your plan should include controls to assure that the fish are fully iced or that the transport temperatures are maintained below 4.4°C throughout transport.
Additionally, when a firm acts as a primary processor receiving anchovies directly from the harvest vessels, the firm should ensure that the fish were properly handled onboard the vessels. For example, FDA recommends either conducting histamine testing at receipt or obtaining harvest vessel records. Additionally, we recommend monitoring internal temperatures of the fish as they are off-loaded from the harvest vessels and conducting a sensory examination to ensure that the fish do not show signs of decomposition.
Your firm should assess the need to include a critical control point or multiple critical control points to address the following:
a. Cumulative exposure times of the fish to ambient/unrefrigerated temperatures to control Clostridium botulinum growth and toxin formation, along with histamine formation until the fish have achieved full fermentation (i.e., shelf stability). FDA recommends when whole fish remain uneviscerated (i.e., with the belly cavity intact) during processing, that cumulative exposure times to temperatures above 21 °C be limited to 2 hours from the start of the first salting step, identified in your plan as "(b)(4) ," through all subsequent steps, until a water activity (Aw) of <0.85 or water phase salt (WPS) > 20% is achieved.
b. Pre-formed Clostridium botulinum toxin. Currently, FDA recommends either including a boiling step where the uneviscerated/whole fish are boiled for 10 minutes prior the start of processing; or where the finished fish sauce is boiled for 10 minutes. Alternatively, your firm may present a scientific study demonstrating that your fermentation process will provide an equivalent control in eliminating pre-formed Clostridium botulinum toxin.
c. Assure that uneviscerated fish intended for processing do not exceed 5 inches in length.
In addition, when conducting your hazard analysis, your firm should consider the need for any storage critical control points that may be necessary to control Clostridium botulinum growth and toxin formation and histamine, after the boiling of the uneviscerated fish.
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 HACCP plan does not list a critical limit to control either time or temperature exposures at the (b)(4) critical control point to control the identified hazard of Clostridium botulinum growth and toxin formation.
Cumulative exposure times should be limited to 2 hours OR the fish should remain refrigerated at <3.3°C or heated above 55°C. However, because it appears that your firm does not control fermentation temperatures, as an alternate strategy your firm should ensure that the products achieve an Aw of <0.85 or a WPS of>20% within 2 hours to prevent Clostridium botulinum growth and toxin formation during drying (i.e., after boiling of the whole fish to control pre-formed Clostridium botulinum ~ever, should your firm choose to (b)(4) Clostridium botulinum toxin, you will need to include exposure times during the Fish Ferment Pond processing step prior to the fish achieving an Aw of <0.85 or a WPS of >20% as part of the cumulative exposure times to control histamine formation.
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 11 0). 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. Are-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 there-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 reinspection-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: Mildred Benjamin, Consumer Safety Officer, 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. Benjamin via email at email@example.com.
Office of Compliance
Center for Food Safety
and Applied Nutrition