# FDA 483 - VA New York Harbor Healthcare System - January 29, 2025

Source: https://www.keypedia.com/records/483/va-new-york-harbor-healthcare-system/cda85486-0463-400a-87e4-475ac4c8557b

> FDA 483 for VA New York Harbor Healthcare System on January 29, 2025. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: VA New York Harbor Healthcare System
- Inspection Date: 2025-01-29
- Product Type: biologics
- Office Name: New York District Office
- Summary: An FDA inspection of VA New York Harbor Healthcare System's Blood Bank in Brooklyn, NY, revealed a significant failure to maintain adequate records. The facility did not document investigations or corrective actions for discrepancies in patient testing results and lacked documentation for over-temperature alarm checks on critical units. These findings indicate deficiencies in quality control and record-keeping practices.

## Related Officers

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

Company: https://www.keypedia.com/companies/va-new-york-harbor-healthcare-system/669f4c4c-98f5-470d-abde-5180f8a7bc76

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