Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|College Park, MD 20742|
FEB 5, 2016
VIA EXPRESS DELIVERY
Mr. Sutin Sawaengsin, Factory Division Manager
Unicord Public Company Ltd.
56/5 Moo 3, Baansrimuang Road, Thasai
Muang, Samut Sakhon 74000
Reference No. # 488033
Dear Mr. Sutin Sawaengsin:
We inspected your seafood processing facility Unicord Public Company Ltdlocatedat 56/5 Moo 3, Baansrimuang Road, Thasai, Muang, Samut Sakhon, Thailand,on September 10-11, 2015. During that 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, 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 sent via email onSeptember 29, 2015.Your response included various documents, including a revised HACCP plan for “Value Added Canned Tuna,” HACCP monitoring records, training records, sanitation records, traceability records, and photos of corrections to the observations of concern noted on the FDA-483. However, our evaluation of the documentation revealed that the response was not adequate, 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 canned tuna 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 4th Edition of the Hazards Guide can be found on our web site at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/FishandFisheriesProductsHazardsandControlsGuide/default.htm
Your significant deviations are as follows:
1. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm’s HACCP plan for “Value Added Canned Tuna’ lists monitoring procedures at the following critical control points that are not adequate to control their respective food safety hazards:
a. Frozen Tuna Receiving (“CCP 1C”)
o At the Receiving critical control point your plan lists that you will collect a minimum of 18 samples for histamine testing from each “lot” of fish to control scombrotoxin formation. FDA has not objected to applying a minimum sample size of 18 samples for lots of 25 MT or less, but considers that amount insufficient to provide the necessary safety assurances for larger lots. The investigator observed and your plan defines that a “lot” is “(b)(4) from the same source.” The (b)(4) lots of frozen tuna are divided and transported to your firm in (b)(4) of (b)(4). Your firm collects 18 samples from the (b)(4), then (b)(4) from each of the (b)(4), (b)(4), and (b)(4) for a total of 27 samples. FDA recommends that sample collection be representative of the lot and spread equally throughout the lot. With the current method of sample collection, one fifth of the product (b)(4) is heavily influencing the sampling results and one fifth (b)(4) is not sampled at all.
o At the Receiving critical control point, the sample size used to monitor the decomposition critical limit is inadequate to control scombrotoxin formation. Your plan indicates that 118 fish will be analyzed for decomposition. The minimum sample size recommended in the Hazards Guide does not provide the necessary safety assurances for very large lots, such as (b)(4). Your sample size should be increased to provide a safety assurance comparable to 118 fish representing a smaller lot, such as 25 MT.
b. Pre-cooking (“CCP 3C”)
o At the Pre-cooking critical control point, the monitoring procedures listed in your HACCP plan of inserting a dial thermometer into the mid-dorsal position of the fish does not take into account the coldest point of the cooker. In addition, your monitoring records do not document this information. We also noted that your heat distribution study does not support the reduced number of samples (24 fish per pre-cooker) as the monitoring frequency for EPIPT.
2. You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not follow the monitoring frequency of “24 fish per Pre-cooker” at the Precooking critical control point to control scombrotoxin formation listed in your HACCP plan for “Value Added Canned Tuna.” Specifically, the monitoring record titled “Back Bone Temperature Record,” provided in your response indicates only 12 internal temperature observations were conducted for each precooker.
3. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans for “Value Added Canned Tuna” at the following critical control points are not appropriate:
a. Frozen Tuna Receiving (“CCP 1C”)
o Your corrective action indicates you will analyze an additional 60 tuna for histamine when you exceed the decomposition critical limit. The 60 tuna should include the fish found to be decomposed, with the remaining fish collected from throughout the lot.
b. Precooked Fish Processing (CCP 5B”)
o Your corrective action indicates you will “hold and isolate the affected batch to consult the process authority to determine product disposition.” FDA recommends that product that has been exposed to unsafe conditions that could result in the formation of Staphylococcus aureus toxin should be either destroyed or diverted to a non-food use. Alternative dispositions that involve either testing or potential consumption of the affected product do not provide the necessary safety assurances.
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)(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.
You should respond in writing within thirty (30) 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
Please send your reply to Food and Drug Administration, Attention: Brandon Bridgman, Consumer Safety Officer, Food Adulteration Assessment Branch (HFS-607), Division of Enforcement, Office of Compliance, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Mr. Brandon Bridgman via email at Brandon.Bridgman@fda.hhs.gov.
William A. Correll
Office of Compliance
Center for Food Safety
and Applied Nutrition