# FDA 483 - Chemence Medical Products, Inc. - February 23, 2018

Source: https://www.keypedia.com/records/483/chemence-medical-products-inc/0e97992e-76d3-405f-a329-9b07d2a600d3

> FDA 483 for Chemence Medical Products, Inc. on February 23, 2018. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chemence Medical Products, Inc.
- Inspection Date: 2018-02-23
- Product Type: other
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Chemence Medical Products, Inc. in Alpharetta, GA, revealed significant deficiencies across four observations related to quality system procedures. The firm failed to adequately establish procedures for acceptance activities, process revalidation, equipment calibration, and rework of nonconforming products. These issues indicate a lack of robust quality control and documentation practices.

## Related Officers

- [Brenda Rivera](https://www.keypedia.com/people/brenda-rivera/b7f32d1e-c9a2-444c-a14b-968367db3264)
- [investigator](https://www.keypedia.com/people/sayeeda-hdabe/eaadc7cf-5f22-47c2-ba02-437efe0a5267)

Company: https://www.keypedia.com/companies/chemence-medical-products-inc/f7174d27-ee32-40e9-9287-0c2661cea993

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7