# FDA 483 - J.M Huber Micropowders, Inc - June 25, 2021

Source: https://www.keypedia.com/records/483/jm-huber-micropowders-inc/3e0fd1b3-f761-4982-a483-919a904e486e

> FDA 483 for J.M Huber Micropowders, Inc on June 25, 2021. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: J.M Huber Micropowders, Inc
- Inspection Date: 2021-06-25
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of J.M Huber Micropowders, Inc. in La Mirada, CA, revealed significant deficiencies in their manufacturing processes for non-sterile API. The firm was cited for producing batches using unsupported validation data, failing to document deviations, and not calibrating critical equipment. Additionally, the inspection found that GMP-related computerized systems lacked proper validation, indicating a need for improved quality control and adherence to regulatory standards.

## Related Officers

- [Pharmaceutical investigator](https://www.keypedia.com/people/bryan-a-galvez/d1e52abc-5b56-4ffb-af22-90e6733fb73a)

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