# FDA 483 - Medefil Incorporated - April 21, 2025

Source: https://www.keypedia.com/records/483/medefil-incorporated/3c3e9aa6-79c7-40ce-9e78-a0f762e3d3ce

> FDA 483 for Medefil Incorporated on April 21, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medefil Incorporated
- Inspection Date: 2025-04-21
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: Medefil, Inc., a sterile drug manufacturer in Glendale Heights, IL, was cited for significant deficiencies during an FDA inspection. The observations primarily concern inadequate investigations into unknown impurities in drug products, insufficient controls over computerized systems for production data, and failures in equipment cleaning and laboratory procedure adherence. These issues indicate a lack of robust quality control and sanitation practices that could impact product safety and purity.

## Related Officers

- [JeanClaude Garay](https://www.keypedia.com/people/jeanclaude-garay/62e387aa-73d3-4f69-8cc2-5607b7963d7f)
- [Michele L. Glendenning](https://www.keypedia.com/people/michele-l-glendenning/a3c23a43-634c-4140-807b-c17fbc03bb00)
- [Angela C. Welker](https://www.keypedia.com/people/angela-c-welker/b732b19f-c8e8-43b0-bc81-8dcde8a53c84)
- [Jean Claude Garay](https://www.keypedia.com/people/jean-claude-garay/e85f215e-5a7e-40f7-9214-74b18de1792a)

Company: https://www.keypedia.com/companies/medefil-incorporated/a2030c44-2817-4b9c-8416-f5af7691b9c5

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669