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

Source: https://www.keypedia.com/records/483/apex-international-mfg-inc/cf6079d9-836c-435d-8be0-0eb734c1ddf9

> FDA 483 for Apex International Mfg., Inc on June 12, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Apex International Mfg., Inc
- Inspection Date: 2026-06-12
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: 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.

## Related Officers

- [Soyinka S. Eneng](https://www.keypedia.com/people/soyinka-s-eneng/a7f69c63-1beb-4c59-9ccd-6e35c49a10c5)

Company: https://www.keypedia.com/companies/apex-international-mfg-inc/7390b23d-581f-430f-b167-46089d661221

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d