483
Apex International Mfg., IncApex International Mfg., Inc – FDA 483, Jun 12, 2026
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.
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