Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/itc-global-trading-inc-dba-itc-intertrade-inc-518549-04042017
Timestamp: 2020-03-29 12:24:02
Document Index: 498249142

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

ITC Global Trading, Inc dba ITC Intertrade, Inc. - 518549 - 04/04/2017 | FDA
ITC Global Trading, Inc dba ITC Intertrade, Inc. - 518549 - 04/04/2017
ITC Global Trading, Inc dba ITC Intertrade, Inc. MARCS-CMS 518549 — April 04, 2017
ITC Global Trading, Inc dba ITC Intertrade, Inc.
1505 Sawyer St. Ste. B.
Dear: Mr. John Wong,
The U.S. Food and Drug Administration (FDA) inspected your seafood importer facility, located at 1505 Sawyer St, Houston, TX on 21712017, 2/8/2017, and 2/10/2017. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123). The specific requirements for imported fish and fishery products are set out in 21 CFR 123.12. As an importer of fish or fishery products, you must operate in accordance with the requirements of Part 123. 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 assurances do not exist that the imported fish or fishery product has been processed under conditions that are equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4), and will be denied entry.
Because our inspection identified serious violations for 21 CFR Part 123, your frozen (b)(4) mackerel and frozen (b)(4) fish cake are adulterated under Section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4)), 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 homepage at www.fda.gov.
1. You do not have or have not implemented written verification procedures for ensuring that fish you import are processed in compliance with the Seafood HACCP regulation. The written verification procedures shall list, at minimum: (1) product specifications designed to ensure that the product is not adulterated under the Act because it may be injurious to health or have been processed under insanitary conditions; and (2) affirmative steps. 21 CFR 123.12(a)(2). This violation was noted during the previous inspections in 2016, 2011 and 2004.
Specifically, your firm does not have written verification procedures for the imported Frozen (b)(4) Mackerel and Frozen Fried Fish Cakes, as required by 21 CFR 123.12(a)(2)(i) & (ii).
Your firm must properly implement written affirmative steps to ensure that the fish and fishery product(s) that you import are processed in accordance with the seafood HACCP regulation, as required by 21 CFR 123.12 (a)(2)(i) & (ii).
2. You have failed to maintain records that document the performance and results of affirmative steps, as required by 21 CFR 123.12(c) and 123.9.
Specifically, you failed to provide documentation that the seafood products that you have imported over the last (b)(4) years, including but not limited, frozen (b)(4) mackerel and frozen (b)(4) fish cake, are processed according to seafood regulations.
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 "detention without physical examination," seize your product(s), and/or enjoin your firm from further violating the Act.
Your written response should be sent to Stephanie Pogue, Compliance Officer, U.S. Food and Drug Administration, North Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions about this letter, please contact Compliance Officer Stephanie Pogue at (214) 253-4995 or by e-mail at Stephanie.Pogue@fda.hhs.gov.