# FDA 483 - Catalent Maryland Inc - March 10, 2023

Source: https://www.keypedia.com/records/483/catalent-maryland-inc/0550756e-4e9b-4c8e-9d9d-ff1444350806

> FDA 483 for Catalent Maryland Inc on March 10, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Catalent Maryland Inc
- Inspection Date: 2023-03-10
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Catalent Maryland, Inc. in Hanover, MD, a drug substance manufacturer, revealed two observations related to significant failures in the firm's Quality Unit. The Quality Unit failed to ensure the integrity of the Quality Management system by not properly managing change controls and also failed to address issues impacting product quality by not following deviation procedures.

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## Related Officers

- [Biologist](https://www.keypedia.com/people/biologist/bd950a8f-4352-485f-aee8-d912193c94ee)

Company: https://www.keypedia.com/companies/catalent-maryland-inc/fbdaa987-e6a7-466f-b42b-1f23193725d8

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd