# FDA 483 - Catalent Pharma Solutions, LLC - July 22, 2025

Source: https://www.keypedia.com/records/483/catalent-pharma-solutions-llc/c58fc986-4273-4b7f-9188-8df45c60b182

> FDA 483 for Catalent Pharma Solutions, LLC on July 22, 2025. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Catalent Pharma Solutions, LLC
- Inspection Date: 2025-07-22
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: Catalent Pharma Solutions, LLC in Madison, WI, a drug substance manufacturer, was cited for significant deficiencies across its operations. The inspection revealed inadequate laboratory controls, failures in microbial and cross-contamination risk assessments for open processes, and an ineffective environmental monitoring program. Additionally, the firm lacked a robust cleaning and sanitization program, exhibited poor adherence to standard operating procedures, and had facility and equipment design issues compromising sanitary conditions.

## Related Officers

- [other](https://www.keypedia.com/people/jeanne-m-fringer/4d970694-416e-42d6-9ec3-7bf3e337fb9a)
- [Jacek Cieslak](https://www.keypedia.com/people/jacek-cieslak/81b12add-49f1-4dfd-bcb1-60bc5b212b68)

Company: https://www.keypedia.com/companies/catalent-pharma-solutions-llc/33fc8520-6cf9-4a0d-b693-24ca8795dd75

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d