# FDA 483 - Catalent Maryland, Inc. - April 09, 2025

Source: https://www.globalkeysolutions.net/records/483/catalent-maryland-inc/6364cf7a-9c9e-4c45-91b6-3878217bd57b

> FDA 483 for Catalent Maryland, Inc. on April 09, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Catalent Maryland, Inc.
- Inspection Date: 2025-04-09
- Product Type: biologics
- Office Name: Baltimore District Office
- Summary: An FDA inspection of Catalent Maryland, Inc. in Baltimore, MD, a biological drug product manufacturer, revealed two significant observations. The firm failed to follow procedures designed to prevent microbiological contamination during sterile filling operations and did not maintain its manufacturing buildings in a good state of repair, specifically noting floor damage in a critical area. These issues indicate potential risks to the sterility and quality of drug products.

## Related Documents

- [483 - 2019-11-04](https://www.globalkeysolutions.net/records/483/catalent-maryland-inc/d97a7545-caa5-4f02-9927-f9653723ba5a)

## Related Officers

- [FDA_PERSONNEL](https://www.globalkeysolutions.net/people/lizaida-perez/686fbdca-bfd7-4a73-990a-d8a97e6b88b7)

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

Office: https://www.globalkeysolutions.net/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa