# FDA 483 - Praxis Powder Technology, Inc. - July 29, 2022

Source: https://www.keypedia.com/records/483/praxis-powder-technology-inc/4e71af29-f0aa-472d-8b16-5e4d91899fa3

> FDA 483 for Praxis Powder Technology, Inc. on July 29, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Praxis Powder Technology, Inc.
- Inspection Date: 2022-07-29
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Praxis Powder Technology, Inc. in Queensbury, NY, a contract manufacturer of medical implants, revealed significant deficiencies in their corrective and preventive action (CAPA) system. Specifically, the firm failed to adequately document investigations, sampling plans, risk assessments, and preventative measures related to product discoloration and potential cross-contamination issues. These findings indicate a serious breakdown in quality system controls that could impact product quality and patient safety.

## Related Officers

- [Jacqueline S. Warner](https://www.keypedia.com/people/jacqueline-s-warner/d001f4ec-db46-4d78-a5dd-efea7ddfb893)

Company: https://www.keypedia.com/companies/praxis-powder-technology-inc/2524d7e2-13c3-49dc-bd11-f5964a8e57eb

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961