# FDA 483 - Montefiore Medical Center Blood Bank - April 29, 2025

Source: https://www.globalkeysolutions.net/records/483/montefiore-medical-center-blood-bank/821bb032-715d-4850-81b5-11c6f47f9e35

> FDA 483 for Montefiore Medical Center Blood Bank on April 29, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Montefiore Medical Center Blood Bank
- Inspection Date: 2025-04-29
- Product Type: biologics
- Office Name: New York District Office
- Summary: An FDA inspection of Montefiore Medical Center's Blood Bank in Bronx, NY, revealed significant deficiencies in record-keeping and adherence to standard operating procedures. Observations included untraceable blood products, incomplete irradiation records, undocumented product movements, and failures in quality control documentation. These issues indicate a concerning lack of control over critical processes for blood and blood components.

## Related Documents

- [483 - 2023-05-18](https://www.globalkeysolutions.net/records/483/montefiore-medical-center-blood-bank/4626eaa0-f036-4975-9af4-739cea093a0b)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/irina-gaberman/c863b2de-4c64-40d2-a390-289d293e5a8f)

Company: https://www.globalkeysolutions.net/companies/montefiore-medical-center-blood-bank/7033c869-0208-41d0-9a7a-2ea327dba84a

Office: https://www.globalkeysolutions.net/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d