Apex International Mfg., IncJune 12, 2026

FDA 483 - Apex International Mfg., Inc - June 12, 2026

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Record Details

An FDA inspection of Apex International Mfg. LLC., a human drug manufacturer in Eden Prairie, MN, revealed two significant observations. The firm's procedures for supplier qualification were found to be inadequate, specifically lacking a defined requalification process. Additionally, drug products were observed stored improperly on the warehouse floor, potentially compromising their identity, strength, quality, and purity.

Company: Apex International Mfg., Inc
Inspection Date: June 12, 2026
Product Type: Drugs
Office: Minneapolis District Office
Person: Soyinka S. Eneng

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