FDA WARNING_LETTER - Wang Globalnet - April 25, 2014

On April 22 and 25, 2014, the FDA inspected Wang Globalnet's seafood importer establishment in Brooklyn, NY, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), specifically 21 CFR 123.12 for imported fish and fishery products.

The primary violation was the firm's failure to fully implement an affirmative step to ensure imported boiled and dried anchovy products were processed in accordance with seafood HACCP regulations, as required by 21 CFR 123.12(a)(2)(ii). An FDA sample of boiled and dried anchovy, imported under entry number (b)(4), was found to be uneviscerated, leading to its refusal of admission on (b)(4) and deeming it adulterated under Section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act). This also renders the product adulterated under Section 402(a)(4) of the Act due to insanitary conditions.

Additionally, the facility failed to renew its biennial registration as required by Section 415(a)(3) of the Act and 21 CFR Part 1, Subpart H, which is a prohibited act under Section 301(dd) of the Act.

Wang Globalnet must register its