# FDA 483 - Catalent Maryland Inc - Unknown Date

Source: https://www.keypedia.com/records/483/catalent-maryland-inc/6fe2c9ac-b15f-41dc-bb94-94ec7a881cd0

> FDA 483 for Catalent Maryland Inc on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Catalent Maryland Inc
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Paragon Gene Therapy/Catalent Maryland Inc., a biologics/cell therapy manufacturer in Harmans, Maryland, revealed significant deficiencies across multiple areas. The firm failed to consistently follow standard operating procedures, exhibited inadequate deviation management and trending, and lacked sufficient controls to prevent material mix-ups. Additionally, issues were noted with preventing recurrence of cell culture vessel defects and establishing expiration dates for manufacturing media.

## Related Documents

- [EIR - 2021-11-17](https://www.keypedia.com/records/eir/catalent-maryland-inc/03bb4edc-783b-4f67-85cd-78c9ab7171f4)
- [483 - 2021-11-17](https://www.keypedia.com/records/483/catalent-maryland-inc/3d25d720-4dc4-450c-a351-5d2f1516da0e)
- [483 - 2023-03-10](https://www.keypedia.com/records/483/catalent-maryland-inc/0550756e-4e9b-4c8e-9d9d-ff1444350806)
- [483 - 2025-04-28](https://www.keypedia.com/records/483/catalent-maryland-inc/d609aefc-35f3-4b29-9bbc-b91d1af8559c)
- [483 - 2025-04-28](https://www.keypedia.com/records/483/catalent-maryland-inc/a1f090bf-4d0e-40aa-af63-d03a29bdf9a7)

## Related Officers

- [Wanda E. Pagan, Ph.D., Biologist](https://www.keypedia.com/people/wanda-e-pagan-phd-biologist/4faacd9a-9de9-427e-9935-17f81da87fa9)
- [Priscilla M. Jimenez, CSO, Lead Inspector](https://www.keypedia.com/people/priscilla-m-jimenez-cso-lead-inspector/6f26853f-d339-4e26-8b6c-f75ad7113b15)
- [Wei Bo Liang, Ph.D., Visiting Associate](https://www.keypedia.com/people/wei-bo-liang-phd-visiting-associate/9795ea7e-825d-446c-b917-4c7c71777617)
- [Andrew Byrnes, Ph.D., Supv. Res. Microbiologist](https://www.keypedia.com/people/andrew-byrnes-phd-supv-res-microbiologist/eba9a12a-6a14-441c-b696-9cd0895d1b91)

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