# FDA 483 - Catalent Greenville Inc - July 12, 2019

Source: https://www.globalkeysolutions.net/records/483/catalent-greenville-inc/bc6cefe3-948d-478e-9077-d2727d1b46a4

> FDA 483 for Catalent Greenville Inc on July 12, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Catalent Greenville Inc
- Inspection Date: 2019-07-12
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Mayne Pharma Inc in Greenville, NC, revealed significant deficiencies in laboratory controls and quality system investigations. The firm failed to establish scientifically sound specifications and test procedures for environmental monitoring and water testing, and did not thoroughly review unexplained discrepancies or out-of-specification/out-of-trend results for drug products.

## Related Documents

- [483 - 2025-10-24](https://www.globalkeysolutions.net/records/483/catalent-greenville-inc/4533beac-cc6a-41f8-8d08-00ecde98205c)

## Related Officers

- [LaKeesha Foster](https://www.globalkeysolutions.net/people/lakeesha-foster/30a5b325-6718-44c0-961f-72487ac3e865)
- [CO CDER OMQ](https://www.globalkeysolutions.net/people/claire-minden/f48982ad-244e-41a8-932a-5d7a2392f0e3)

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