Apollo Import Export Inc. – FDA Warning Letter, May 2, 2023

On September 26, 2023, the FDA issued a Warning Letter to Apollo Import Export Inc. following a Foreign Supplier Verification Program (FSVP) inspection on May 2, 2023, and previous inspections in April 2021 and June-July 2022. The firm was found non-compliant with section 805 of the FD&C Act and 21 CFR part 1 subpart L, which mandates risk-based activities to verify imported food meets U.S. safety standards.

Significant violations include: 1. Failure to develop, maintain, and follow an FSVP for any imported foods, as required by 21 CFR 1.502(a). Documents provided by foreign suppliers were deemed insufficient as they lacked evidence of review or application to an FSVP. 2. Failure to verify and document that imported low-acid canned foods, specifically Adjika (Red Pepper Tomato Dip), Hot Eggplant Spread (Caviar), and Imam Bayaldi (Eggplant Spread), were produced in accordance with 21 CFR part 113, as required by 21 CFR 1.502(b)(1).

Additionally, the firm's facility is not currently registered with the FDA, a violation of section 415 of the FD&C Act and 21 CFR part 1, subpart H, requiring biennial registration renewal