# FDA 483 - Catalent Pharma Solutions, LLC - January 11, 2023

Source: https://www.keypedia.com/records/483/catalent-pharma-solutions-llc/ea296a40-d7a3-4254-8f00-4c9ad8e69edf

> FDA 483 for Catalent Pharma Solutions, LLC on January 11, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Catalent Pharma Solutions, LLC
- Inspection Date: 2023-01-11
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Catalent Pharma Solutions LLC in Winchester, KY, revealed significant deficiencies in laboratory record review processes. The firm failed to ensure a second person reviewed original records for accuracy, impacting both microbial plate counts and raw material identity testing data. These lapses indicate a serious concern regarding data integrity and quality control within the manufacturing process.

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Company: https://www.keypedia.com/companies/catalent-pharma-solutions-llc/12f42026-6a34-4cfe-936d-3646a0e34c8d

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22