# FDA 483 - Lenox Hill Hospital - April 01, 2024

Source: https://www.keypedia.com/records/483/lenox-hill-hospital/2ef9c4e4-0bee-4ebc-8ae2-478e9977442a

> FDA 483 for Lenox Hill Hospital on April 01, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lenox Hill Hospital
- Inspection Date: 2024-04-01
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Lenox Hill Hospital's Blood Bank in New York, NY, revealed significant deficiencies in record-keeping practices. The hospital failed to maintain concurrent records for the distribution of blood and blood components, particularly concerning emergency releases from a satellite facility and discrepancies in electronic system entries. Additionally, the inspection found a lack of records verifying the proper functioning of new scanners used in the blood bank's electronic system.

## Related Officers

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

Company: https://www.keypedia.com/companies/lenox-hill-hospital/18441af6-502b-46b8-9c33-7708b98f315c

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