# FDA 483 - Inova Health Care Services - August 07, 2019

Source: https://www.globalkeysolutions.net/records/483/inova-health-care-services/806a3f5b-8921-481c-bb0b-aa62a119e06c

> FDA 483 for Inova Health Care Services on August 07, 2019. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Inova Health Care Services
- Inspection Date: 2019-08-07
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: An FDA inspection of Inova Health Care Services, a blood bank in Sterling, VA, revealed three significant observations. The firm failed to consistently follow its written standard operating procedures for blood collection, processing, and distribution, including issues with donor screening, phlebotomy, and equipment validation. Additionally, the inspection noted failures in properly presenting educational materials to donors and obtaining necessary post-donation contact information.

## Related Documents

- [483 - 2019-08-07](https://www.globalkeysolutions.net/records/483/inova-health-care-services/0be13067-0462-4ea5-b8fb-400c5205b6fa)
- [483 - 2019-08-07](https://www.globalkeysolutions.net/records/483/inova-health-care-services/010c0059-fbbf-453a-bac0-abb8e43723e7)

## Related Officers

- [Amanda B. Athey](https://www.globalkeysolutions.net/people/amanda-b-athey/6f681ae5-ccab-4a97-89ac-29d9fc53dbdb)
- [La-tasha M. Gunter](https://www.globalkeysolutions.net/people/la-tasha-m-gunter/db9cd9cf-db0a-4c31-9f7c-24760750f34d)

Company: https://www.globalkeysolutions.net/companies/inova-health-care-services/4f75c7d3-a8d5-407d-8fd6-1e6821e47c28

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e