FDA WARNING_LETTER - Kaymile Trading, Inc. - April 24, 2020

The FDA conducted a remote Foreign Supplier Verification Program (FSVP) inspection on April 24, 2020, following an initial on-site inspection on September 6, 2018, at Kaymile Trading, Inc. The inspections aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1 subpart L. The firm was found non-compliant for roasted onion granules, coarse black pepper, and roasted garlic granules. Significant violations include the failure to develop, maintain, and follow an FSVP for roasted onion granules and coarse black pepper (21 CFR 1.502(a)). For roasted garlic granules, the firm did not conduct a hazard analysis (21 CFR 1.504(a)), document foreign supplier approval (21 CFR 1.505(b)), or establish written procedures for importing from approved suppliers (21 CFR 1.506(a)(1)). Additionally, Kaymile Trading, Inc. failed to establish adequate written procedures for supplier verification activities (21 CFR 1.506(b)) and did not conduct or document required verification activities (21 CFR 1.506(e)). The firm also failed to respond to previous FDA 483a observations. The FDA requires prompt corrective action and a written response within 15 working days, including documentation of implemented corrections. Failure to comply may result in refusal of admission, detention without physical examination (DWPE) of products, and prohibition of importation under section 301(zz) of the FD&C Act.