# FDA 483 - Catalent Greenville Inc - October 24, 2025

Source: https://www.globalkeysolutions.net/records/483/catalent-greenville-inc/4533beac-cc6a-41f8-8d08-00ecde98205c

> FDA 483 for Catalent Greenville Inc on October 24, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Catalent Greenville Inc
- Inspection Date: 2025-10-24
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: The FDA inspected Catalent Greenville Inc, a contract drug manufacturer, and issued a Form 483 with three observations. The inspection revealed significant issues across equipment maintenance, microbial testing, and stability program adherence, indicating potential risks to drug product quality and safety. Specifically, observations included unvalidated equipment modifications, worn equipment, inadequate microbial testing and identification, and poor control over stability samples.

## Related Documents

- [483 - 2019-07-12](https://www.globalkeysolutions.net/records/483/catalent-greenville-inc/bc6cefe3-948d-478e-9077-d2727d1b46a4)

## Related Officers

- [Santos E. Camara](https://www.globalkeysolutions.net/people/santos-e-camara/18cea942-f6f9-4dec-9ce9-1c01c39009ce)
- [Investigator ](https://www.globalkeysolutions.net/people/nicole-e-knowlton/8e65400f-249f-45fe-96fc-cb00fec6ae39)

Company: https://www.globalkeysolutions.net/companies/catalent-greenville-inc/11f944f4-641e-45e5-9c6b-3a3a7b1ab8cd

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