# FDA 483 - Catalent Maryland, Inc. - November 04, 2019

Source: https://www.keypedia.com/records/483/catalent-maryland-inc/d97a7545-caa5-4f02-9927-f9653723ba5a

> FDA 483 for Catalent Maryland, Inc. on November 04, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Catalent Maryland, Inc.
- Inspection Date: 2019-11-04
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: An FDA inspection of Catalent Maryland, a drug manufacturer in Baltimore, revealed significant deficiencies in their sterile drug product manufacturing processes and quality control investigations. Observations included inadequate procedures to prevent microbiological contamination, uncertified cleanrooms, and a failure to conduct root cause assessments for unexplained discrepancies. These issues indicate a lack of adherence to good manufacturing practices.

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- [483 - 2025-04-09](https://www.keypedia.com/records/483/catalent-maryland-inc/6364cf7a-9c9e-4c45-91b6-3878217bd57b)

## Related Officers

- [Mindy M. Chou](https://www.keypedia.com/people/mindy-m-chou/3d0e74bf-ad6b-48b5-8b72-cbb29e9c9ce5)
- [issuing_officer](https://www.keypedia.com/people/brandon-l-mariner/c1ff0e66-552d-466a-9b49-a083d0211c94)

Company: https://www.keypedia.com/companies/catalent-maryland-inc/b2f722ce-b6bd-42e6-b648-cec5c4b5f44d

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e