Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bao-international-inc-515749-01302017
Timestamp: 2020-06-01 23:27:09
Document Index: 388640082

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

Bao International Inc - 515749 - 01/30/2017 | FDA
Bao International Inc - 515749 - 01/30/2017
Bao International Inc MARCS-CMS 515749 — January 30, 2017
Edmund F. Tsang
4553 Castle Rd
We inspected your seafood importer establishment, located at 4553 Castle Rd. La Canada, Ca. 91011-1452 on December 13, 2016. 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 (21CFR 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 breaded squid ring and tentacles and frozen seafood mix 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 home page at www.fda.gov.