FDA WARNING_LETTER - International General Trading Corp. - April 15, 2021

The FDA conducted a remote Foreign Supplier Verification Program (FSVP) inspection of International General Trading Corp. from March 16 to April 15, 2021, following a previous inspection on August 21, 2018. The inspections aimed to determine compliance with section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the implementing FSVP regulation in 21 CFR part 1 subpart L. The FDA found that the company failed to develop, maintain, and follow an FSVP for specific imported products, including (b)(4) Noodles, (b)(4) Wafers, and (b)(4) Hazelnut Spread, violating section 805 of the FD&C Act and 21 CFR 1.502(a). The company had not responded to previous Form FDA 483a observations. The FDA requires a written response within fifteen working days detailing specific corrective actions, supported by documentation such as a copy of the FSVP and records demonstrating its implementation. Failure to adequately address these violations may result in refusal of admission for imported food products, detention without physical examination (DWPE) under Import Alert # 99-41, and prohibition of importation under section 301(zz) of the FD&C Act.