# FDA 483 - Catalent Pharma Solutions, LLC - January 30, 2026

Source: https://www.keypedia.com/records/483/catalent-pharma-solutions-llc/511c9d12-351a-44a8-b9a2-bf7285abafc4

> FDA 483 for Catalent Pharma Solutions, LLC on January 30, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Catalent Pharma Solutions, LLC
- Inspection Date: 2026-01-30
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Catalent Pharma Solutions, LLC in Saint Petersburg, FL, a contract drug manufacturer, revealed significant deficiencies in their quality control unit and procedures for preventing microbiological contamination. The firm failed to control laboratory documentation and retain original raw data, leading to data integrity concerns. Additionally, the facility lacked adequate procedures and testing to prevent objectionable microorganisms in non-sterile drug products, despite environmental monitoring indicating their presence.

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- [483 - 2023-07-21](https://www.keypedia.com/records/483/catalent-pharma-solutions-llc/b53d3803-0505-4856-999c-33b3e1fb1bda)

## Related Officers

- [Denny Y. Fernandez](https://www.keypedia.com/people/denny-y-fernandez/e1ba1526-a950-4929-875e-056bda4608c4)
- [investigator](https://www.keypedia.com/people/tammy-t-brown/d83095ba-80a1-4006-b429-d8c0d49fcd2b)
- [Investigator ](https://www.keypedia.com/people/nicole-e-knowlton/8e65400f-249f-45fe-96fc-cb00fec6ae39)

Company: https://www.keypedia.com/companies/catalent-pharma-solutions-llc/d29a124f-fdcb-4108-9eac-661149b4d20e

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6