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

Source: https://www.globalkeysolutions.net/records/483/abeona-therapeutics-inc/88f2b3aa-69a0-4242-85dd-93a51d91ec8d

> 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: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Abeona Therapeutics Inc. in Cleveland, OH, received an FDA Form 483 with five observations related to its cell and gene therapy manufacturing. The inspection revealed significant deficiencies in aseptic processing controls, quality control of media and reagents, deviation management, retesting procedures for lot release, and disinfectant efficacy studies. These issues indicate potential risks to product sterility and quality, including the release of product lots with out-of-specification results.

## Related Officers

- [Joshua Kuten](https://www.globalkeysolutions.net/people/joshua-kuten/1e6dce63-070b-4c13-8cc1-23a0b834d81e)
- [Christine Harman](https://www.globalkeysolutions.net/people/christine-harman/916fa691-117d-446b-8b53-7413194e3eda)
- [Bao-Ngoc Nguyen](https://www.globalkeysolutions.net/people/bao-ngoc-nguyen/a8894eec-762c-45fe-a215-6a685fa482b9)
- [Ou Olivia Ma](https://www.globalkeysolutions.net/people/ou-olivia-ma/d1d1db58-2dca-436c-b934-522cdddb7df1)
- [Alyssa Kioussi](https://www.globalkeysolutions.net/people/alyssa-kioussi/e71fd038-ed92-47b2-b04b-9ccb0089e9d9)

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

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd