FDA 483 - KAREEM MART INC - January 21, 2021

KAREEM MART INC, located in Garden City, MI, was inspected regarding its Foreign Supplier Verification Program (FSVP). The inspection revealed significant deficiencies, including inadequate written assurances from foreign suppliers, a lack of documented corrective actions for non-compliant suppliers, and failure to establish proper written procedures for supplier approval. Additionally, the firm lacked a qualified individual to develop its FSVP and failed to provide unique facility identifiers during import filings.