# FDA 483 - Elmhurst Hospital Center - February 01, 2019

Source: https://www.globalkeysolutions.net/records/483/elmhurst-hospital-center/39c97f86-67d0-4245-a3ea-3e072f42c0d9

> FDA 483 for Elmhurst Hospital Center on February 01, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Elmhurst Hospital Center
- Inspection Date: 2019-02-01
- Product Type: biologics
- Office Name: New York District Office
- Summary: An FDA inspection of Elmhurst Hospital Center's Blood Bank revealed significant deficiencies in maintaining and following written standard operating procedures for the processing, storage, and distribution of blood and blood components. The facility also failed to maintain adequate processing, quality control, and general records, particularly concerning platelet units and pH meter calibration. These issues indicate a lack of robust control over critical blood bank operations.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/elmhurst-hospital-center/74690a39-d6b6-4a3d-9699-66106822d4ad

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