FDA WARNING_LETTER - Aspen Sales Group - June 10, 2020

The FDA conducted a remote Foreign Supplier Verification Program (FSVP) inspection of Aspen Sales Group from May 29 to June 10, 2020, following an initial on-site inspection on March 29, 2018. The inspections aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1 subpart L, which mandate risk-based activities for imported food to meet U.S. food safety standards.

Aspen Sales Group was found non-compliant, specifically lacking FSVPs for imported Refined Sugar and Fries. Significant violations included: 1. Failure to develop, maintain, and follow an FSVP for imported foods (21 CFR 1.502(a)). 2. Absence of written procedures for approving foreign suppliers based on performance and risk (21 CFR 1.506(a)(1)). 3. Failure to establish adequate written procedures for foreign supplier verification activities (21 CFR 1.506(b)). 4. Insufficient documentation that hazard analyses for imported foods, such as Frozen French Fries, were conducted by a qualified individual (21 CFR 1.504(d)). 5. Failure to determine and document the frequency of required verification activities (21 CFR 1.506(d)), specifically for Frozen French Fries. 6. Failure to conduct and document periodic supplier