# FDA 483 - J.M Huber Micropowders, Inc - February 11, 2026

Source: https://www.keypedia.com/records/483/jm-huber-micropowders-inc/8b4787cb-8c76-49ad-b546-bc7930627332

> FDA 483 for J.M Huber Micropowders, Inc on February 11, 2026. 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: 2026-02-11
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: J.M. Huber Micropowders, Inc. in La Mirada, CA, received a Form 483 with three observations related to manufacturing process control, stability testing, and laboratory data integrity. The firm failed to demonstrate reproducible manufacturing processes, lacked an adequate stability testing program, and exhibited insufficient controls over laboratory systems, including data access and documentation. These issues indicate significant concerns regarding product quality and data reliability.

## Related Documents

- [483 - 2021-06-25](https://www.keypedia.com/records/483/jm-huber-micropowders-inc/3e0fd1b3-f761-4982-a483-919a904e486e)

## Related Officers

- [Lillian S. Wu](https://www.keypedia.com/people/lillian-s-wu/b1f6643c-ac01-43e5-8ce2-e6f4fdba9d35)
- [Tareq W. Haddad](https://www.keypedia.com/people/tareq-w-haddad/5dcb10ba-950c-4dea-b351-0b129675f6d2)
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- [Devisree P. Mattigiri](https://www.keypedia.com/people/devisree-p-mattigiri/ecaf86a3-b2b0-4b07-907f-92632c3bbba9)

Company: https://www.keypedia.com/companies/jm-huber-micropowders-inc/29e05493-3c2b-4d4b-ac8d-da0ba1cefba8

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6