# FDA 483 - Catalent Pharma Solutions LLC - May 24, 2024

Source: https://www.keypedia.com/records/483/catalent-pharma-solutions-llc/e6b36c23-5e70-4828-b33c-6c20328a4647

> FDA 483 for Catalent Pharma Solutions LLC on May 24, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Catalent Pharma Solutions LLC
- Inspection Date: 2024-05-24
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Catalent Pharma Solutions LLC in Morrisville, NC, from May 21-24, 2024, revealed significant issues with equipment and facility cleaning practices. Inspectors observed biological safety cabinets and laboratory floors that were not cleaned according to established procedures, leading to unidentified residues and substances. These deficiencies indicate a failure to prevent contamination that could compromise drug product quality.

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## Related Officers

- [Travis S. Bradley](https://www.keypedia.com/people/travis-s-bradley/4d7756cb-65fd-4bd6-be24-25710668e6d8)
- [Richard L. Bartlett](https://www.keypedia.com/people/richard-l-bartlett/602337b9-ac77-41bb-a254-71a9d345335b)

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