# FDA 483 - U.S. Dept. of Veterans Affairs, Northport VA Medical Center - May 18, 2021

Source: https://www.globalkeysolutions.net/records/483/us-dept-of-veterans-affairs-northport-va-medical-center/973829ce-7fbe-4ca9-aba5-98e8ec5fd85d

> FDA 483 for U.S. Dept. of Veterans Affairs, Northport VA Medical Center on May 18, 2021. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: U.S. Dept. of Veterans Affairs, Northport VA Medical Center
- Inspection Date: 2021-05-18
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: The FDA inspected the U.S. Dept. of Veterans Affairs, Northport VA Medical Center Blood Bank, revealing significant deficiencies in record-keeping practices. The facility failed to maintain adequate processing and general records, particularly concerning invalidated test results and the concurrent documentation of blood product distribution. These issues indicate a lack of control over critical blood bank operations and raise concerns about data integrity.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/us-dept-of-veterans-affairs-northport-va-medical-center/8906432f-ad33-4945-899a-7c337bb42f4a

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