# FDA 483 - Abeona Therapeutics, Inc. - Unknown Date

Source: https://www.keypedia.com/records/483/abeona-therapeutics-inc/40cf0ecc-1630-41ed-8c10-d151af32bd7e

> FDA 483 for Abeona Therapeutics, Inc. on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Abeona Therapeutics, Inc.
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: An FDA inspection of Abeona Therapeutics Inc. in Cleveland, OH, revealed significant deficiencies in their cell and gene therapy manufacturing. Observations included inadequate aseptic process controls, insufficient quality control for media and reagents, and a severely inefficient deviation management system. These issues led to delayed investigations, inadequate risk assessments, and the release of potentially compromised product lots.

## Related Documents

- [483 - 2024-03-01](https://www.keypedia.com/records/483/abeona-therapeutics-inc/97434be4-98d1-416e-91bb-18f789c3b89f)
- [483 - Unknown Date](https://www.keypedia.com/records/483/abeona-therapeutics-inc/88f2b3aa-69a0-4242-85dd-93a51d91ec8d)

## Related Officers

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- [Joshua Kulea](https://www.keypedia.com/people/joshua-kulea/20b262e7-bd21-4686-a018-ee81c7c2ecea)

Company: https://www.keypedia.com/companies/abeona-therapeutics-inc/9f67747d-0cf7-495e-a7d5-a4abfa60671a

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4