# Catalent Pharma Solutions, LLC – FDA 483, Jan 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.

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## 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 - 2023-07-21](https://www.keypedia.com/records/483/catalent-pharma-solutions-llc/b53d3803-0505-4856-999c-33b3e1fb1bda) — date: July 21, 2023
- [EIR - 2019-08-28](https://www.keypedia.com/records/eir/catalent-pharma-solutions-llc/b67ab5e5-536c-40cb-a48e-316131669495) — date: August 28, 2019
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- [483 - 2018-06-14](https://www.keypedia.com/records/483/catalent-pharma-solutions-llc/c2a346ed-29f8-40bd-88dd-80e5da48f13c) — date: June 14, 2018
- [483 - 2016-03-25](https://www.keypedia.com/records/483/catalent-pharma-solutions-llc/70f13562-b3ef-4e98-aae6-b2b576bd35e7) — date: March 25, 2016

## Related Officers

- [Danny T. Fernandez](https://www.keypedia.com/people/danny-t-fernandez/81b59afc-efeb-4f37-a04a-4400ae307de0)
- [investigator](https://www.keypedia.com/people/tammy-t-brown/d83095ba-80a1-4006-b429-d8c0d49fcd2b)
- [Damaris Y. Hernandez](https://www.keypedia.com/people/damaris-y-hernandez/ca16093e-047b-4bf1-bcc1-c439cff21e8a)
- [Investigator ](https://www.keypedia.com/people/nicole-e-knowlton/8e65400f-249f-45fe-96fc-cb00fec6ae39)
- [Denny Y. Fernandez](https://www.keypedia.com/people/denny-y-fernandez/e1ba1526-a950-4929-875e-056bda4608c4)

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