# FDA 483 - Montefiore Medical Center Blood Bank - May 18, 2023

Source: https://www.globalkeysolutions.net/records/483/montefiore-medical-center-blood-bank/4626eaa0-f036-4975-9af4-739cea093a0b

> FDA 483 for Montefiore Medical Center Blood Bank on May 18, 2023. 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: 2023-05-18
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Montefiore Medical Center's Blood Bank in Bronx, NY, was cited for significant deficiencies during an FDA inspection. Observations primarily concerned inadequate personnel training for blood irradiator operation, failure to establish and follow written standard operating procedures, and poor record-keeping practices for blood and blood component processing. These issues indicate a lack of control over critical processes, potentially impacting the safety and quality of blood products.

## Related Documents

- [483 - 2025-04-29](https://www.globalkeysolutions.net/records/483/montefiore-medical-center-blood-bank/821bb032-715d-4850-81b5-11c6f47f9e35)

## Related Officers

- [Amy W. Yan-Mai](https://www.globalkeysolutions.net/people/amy-w-yan-mai/00551315-3a03-4327-ab3a-71de5c1577d4)

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

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961