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

Source: https://www.keypedia.com/records/483/catalent-pharma-solutions-llc/93c4cc9c-fd83-4c26-9023-0b4c62c93c56

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

---

## Details

- Record Type: 483
- Company Name: Catalent Pharma Solutions, LLC
- Inspection Date: 2026-01-30
- Product Type: drugs
- Office Name: Florida District Office
- Summary: Catalent Pharma Solutions, LLC in Saint Petersburg, FL, a contract drug manufacturer, was cited for significant deficiencies in quality control and microbiological contamination prevention. The inspection revealed issues with data integrity, including the use of uncontrolled documents and the discarding of original raw data, alongside a failure to adequately test finished capsule products for microbial contamination and establish proper environmental controls.

## Related Documents

- [483 - 2016-03-25](https://www.keypedia.com/records/483/catalent-pharma-solutions-llc/70f13562-b3ef-4e98-aae6-b2b576bd35e7)
- [483 - 2018-06-14](https://www.keypedia.com/records/483/catalent-pharma-solutions-llc/c2a346ed-29f8-40bd-88dd-80e5da48f13c)
- [483 - 2019-02-22](https://www.keypedia.com/records/483/catalent-pharma-solutions-llc/c760f7e9-a3ed-4068-8e39-cf085acfd8af)
- [483 - 2023-07-21](https://www.keypedia.com/records/483/catalent-pharma-solutions-llc/b53d3803-0505-4856-999c-33b3e1fb1bda)

## Related Officers

- [Danny T. Fernandez](https://www.keypedia.com/people/danny-t-fernandez/81b59afc-efeb-4f37-a04a-4400ae307de0)
- [Investigator ](https://www.keypedia.com/people/nicole-e-knowlton/8e65400f-249f-45fe-96fc-cb00fec6ae39)
- [Damaris Y. Hernandez](https://www.keypedia.com/people/damaris-y-hernandez/ca16093e-047b-4bf1-bcc1-c439cff21e8a)
- [investigator](https://www.keypedia.com/people/tammy-t-brown/d83095ba-80a1-4006-b429-d8c0d49fcd2b)

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

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9