# FDA 483 - GERRESHEIMER PEACHTREE CITY LP - December 12, 2022

Source: https://www.keypedia.com/records/483/gerresheimer-peachtree-city-lp/285cc3df-6ab2-4614-8109-2bfa8c84f41e

> FDA 483 for GERRESHEIMER PEACHTREE CITY LP on December 12, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GERRESHEIMER PEACHTREE CITY LP
- Inspection Date: 2022-12-12
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of GERRESHEIMER PEACHTREE CITY LP in Peachtree City, GA, a drug manufacturer, revealed significant deficiencies in quality control and manufacturing processes. Observations included inadequate investigations for product failures, insufficient microbiological testing of water used in manufacturing, and a failure to properly qualify and audit component suppliers. These issues indicate a lack of robust controls to ensure drug product quality and safety.

## Related Officers

- [Susan O. Oladeji](https://www.keypedia.com/people/susan-o-oladeji/307277f8-7704-4ada-8d8d-d77118c6cb77)
- [Miaja Umstead, CSO](https://www.keypedia.com/people/miaja-umstead-cso/e48a9082-5215-4569-ab13-b078f5e55572)

Company: https://www.keypedia.com/companies/gerresheimer-peachtree-city-lp/e0bfae76-17d1-4d35-b7b7-96364dfddd0f

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