Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/t-l-trading-inc-04162015
Timestamp: 2020-07-08 08:35:11
Document Index: 624403487

Matched Legal Cases: ['art 123', 'art 123', 'art 110', 'art 110', 'art 123', '§342', 'art 123', 'art 123', '§ 342', 'art 110', 'art 110', '§ 381', 'art 123', 'art 110']

T & L Trading Inc - 04/16/2015 | FDA
T & L Trading Inc - 04/16/2015
T & L Trading Inc April 16, 2015
T & L Trading Inc
WL# 17-15
Mr. Seung C. Tang
T & L Trading, Inc.
1025 Carob Way
Montebello, CA 90640-6208
We inspected your seafood processing and importer establishment, located at 1025 Carob Way on February 4, 2015 through February 6, 2015. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulations, Title 21, Code of Federal Regulations, Part 123 (21CFR Part 123), and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implemented 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).
As an importer of fish or fishery products, you must operate in accordance with the requirements of 21 CFR 123.12. In accordance with 21 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 123. If the assurances do not exist that the imported fish or fishery products have been processed under conditions equivalent to those required of domestic processors under 21CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Act, 21 U.S.C.§ 342(a)(4).
Accordingly, your live King crab and live halibut are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA’s home page at www.fda.gov.
• You did not comply with 21 CFR 123(a)(2)(i) in that you did not have product specifications that are designed to ensure that the fish and fishery products you import are not injurious to health or have not been processed under insanitary conditions. Specifically, your firm did not have product specifications for live King crab you import from (b)(4) and live halibut from (b)(4).
• You have not implemented an affirmative step in accordance with the seafood HACCP regulation, 21 CFR 123.12(a)(2)(ii). Specifically, your firm did not have an affirmative step for the live halibut you import from (b)(4).
• You are required to monitor the sanitation conditions and practices with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor the safety of water that comes into contact with food or food contact surfaces; condition and cleanliness of food contact surfaces; prevention of cross contamination; with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:
Safety of Water that comes into Contact with Food or Food Contact Surfaces
a. On 02/04/15 mold like substance was observed on water pipes and the side of holding tanks that contained King crab and Hairy crab.
a. On 02/04/15 two dip nets used to scoop live crab and fish were stored vertically against the wall with the net in direct contact with the floor.
b. On 02/04/15 the spray nozzle end of a hose used for cleaning filter fiber was in direct contact with the floor.
a. On 02/04/15 the warehouse had unused equipment, previously used Styrofoam boxes, packaging materials, and miscellaneous items such as pipes, maintenance tools stored throughout the warehouse that can serve as harborage areas for pests. These items were situated in a manner that did not allow sufficient space for cleaning of floors and walls.
We may take further action if you do not promptly correct these violations. 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 the “detention without physical examination,” seize your product(s) and/or enjoin your firm from further violating the Act.
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. You should include in your response documentation, such as HACCP and importer verification records, records that document performance and results of your affirmative steps, HACCP and verification records associated with your activities as a domestic processor, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
This letter may not list all the violations at your facility. You are responsible for ensuring that your seafood importer establishment operates in compliance with the Act and the seafood HACCP regulation (21 CFR Part 123) 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 for your fish or fishery products, including those that you import into the United States. Please send your reply to:
If you have any questions regarding this letter, please contact Denise Howell, Compliance Officer, at (562) 256-9209.