# FDA 483 - Catalent Pharma Solutions LLC - March 04, 2019

Source: https://www.keypedia.com/records/483/catalent-pharma-solutions-llc/fd4377a5-e6b2-433a-984b-3eaa4c1481aa

> FDA 483 for Catalent Pharma Solutions LLC on March 04, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Catalent Pharma Solutions LLC
- Inspection Date: 2019-03-04
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Catalent Pharma Solutions LLC in Morrisville, NC, a contract manufacturer and testing lab, revealed four significant observations. The firm was cited for inadequate procedures to prevent microbial contamination, deficiencies in equipment design and qualification, failures in investigating unexplained discrepancies, and an insufficient preventative maintenance program. These findings indicate moderate issues with the firm's manufacturing controls and quality systems.

## Related Documents

- [483 - 2017-05-19](https://www.keypedia.com/records/483/catalent-pharma-solutions-llc/fc2de3cc-6f44-43d9-8878-8f1a52a74db6)
- [483 - 2020-09-28](https://www.keypedia.com/records/483/catalent-pharma-solutions-llc/d907b32b-1a38-4df3-97fc-d0a2b5622a07)
- [483 - 2022-12-15](https://www.keypedia.com/records/483/catalent-pharma-solutions-llc/c23b58ea-f634-4757-ade1-b3069edda71c)
- [483 - 2024-05-24](https://www.keypedia.com/records/483/catalent-pharma-solutions-llc/e6b36c23-5e70-4828-b33c-6c20328a4647)

## Related Officers

- [Rose Xu](https://www.keypedia.com/people/rose-xu/60ba3a00-9457-4396-aa6d-ffa374fdb7ae)
- [Investigator](https://www.keypedia.com/people/sonya-m-edmonds/a38fad3f-f664-4c52-8e50-78782f56ff18)

Company: https://www.keypedia.com/companies/catalent-pharma-solutions-llc/1080c7fd-2536-4ea5-9a11-18fc6317081b

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