# FDA 483 - J.M. Huber Micropowders, Inc - December 05, 2025

Source: https://www.globalkeysolutions.net/records/483/jm-huber-micropowders-inc/7ab921df-8db1-40cc-9f0d-6f7f8a4d7dbe

> FDA 483 for J.M. Huber Micropowders, Inc on December 05, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: J.M. Huber Micropowders, Inc
- Inspection Date: 2025-12-05
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: J.M. Huber Micropowders, Inc., a Drug API Manufacturer in Quincy, IL, was cited for two significant observations. The firm failed to conduct adequate investigations into out-of-specification (OOS) products and raw materials, including invalidating OOS results without proper protocols and releasing OOS material. Additionally, the company did not maintain adequate records to assure CGMP compliance, specifically regarding disabled audit trails on critical analytical instruments and a lack of procedures for their review.

## Related Officers

- [Tyler M. Peterson](https://www.globalkeysolutions.net/people/tyler-m-peterson/207310ee-260c-4618-a515-9895a56e2ede)

Company: https://www.globalkeysolutions.net/companies/jm-huber-micropowders-inc/6a80bb3c-1275-471b-9afa-7db077b7a116

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