# FDA 483 - Catalent Maryland Inc - November 17, 2021

Source: https://www.keypedia.com/records/483/catalent-maryland-inc/3d25d720-4dc4-450c-a351-5d2f1516da0e

> FDA 483 for Catalent Maryland Inc on November 17, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Catalent Maryland Inc
- Inspection Date: 2021-11-17
- Product Type: biologics
- Office Name: Office of Regulatory Affairs
- Summary: Catalent Maryland, Inc. in Harmans, MD, a manufacturer of gene therapy and vaccine drug substance, was cited for significant deficiencies during an FDA inspection. Observations included manufacturing outside validated ranges, inadequate contamination controls for new products, insufficient quality oversight for investigations and inventory, deficient sample analysis procedures, and inadequate environmental monitoring. The firm also had incomplete investigations and insufficient storage space.

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## Related Officers

- [Donna M. Emerson](https://www.keypedia.com/people/donna-m-emerson/28e0585d-2025-4b15-9635-b2263a524a67)
- [CO CDER OMQ](https://www.keypedia.com/people/claire-minden/f48982ad-244e-41a8-932a-5d7a2392f0e3)

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

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64