# FDA 483 - Medline Industries, Inc. - October 14, 2025

Source: https://www.globalkeysolutions.net/records/483/medline-industries-inc/575ed556-d563-416d-8fe6-8ce35e2cbb2d

> FDA 483 for Medline Industries, Inc. on October 14, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medline Industries, Inc.
- Inspection Date: 2025-10-14
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: Medline Industries, LP in Waukegan, IL, was inspected and received a Form 483 with five observations indicating significant deficiencies in their quality control unit, manufacturing processes, and facility maintenance. The inspection revealed repeated microbial contamination issues, inadequate investigations, poor aseptic practices by operators, and failures in cleaning procedures and facility repair, all posing a risk to drug product quality and purity. The firm failed to ensure CGMP compliance and address systemic quality issues.

## Related Documents

- [483 - 2025-01-16](https://www.globalkeysolutions.net/records/483/medline-industries-inc/b64f39ff-9a5b-4d48-97a2-5af4be26194f)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/gabriel-bermudez-picart/3263ce6e-a27d-4d4b-953c-4477c17aa182)
- [Michele L. Glendenning](https://www.globalkeysolutions.net/people/michele-l-glendenning/a3c23a43-634c-4140-807b-c17fbc03bb00)

Company: https://www.globalkeysolutions.net/companies/medline-industries-inc/ab99df74-d4aa-44f4-aed8-fcb2d3e45280

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