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

Source: https://www.globalkeysolutions.net/records/483/inova-health-care-services/010c0059-fbbf-453a-bac0-abb8e43723e7

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

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## Details

- Record Type: 483
- Company Name: Inova Health Care Services
- Inspection Date: 2019-08-07
- Product Type: Biologics
- Office Name: Department of Health and Human Services
- Summary: Inova Health Care Services, a blood bank located in Sterling, VA, received an FDA Form 483 following an inspection conducted from July 29 to August 7, 2019. The inspection highlighted several critical observations concerning the facility's adherence to regulatory frameworks for blood and blood component handling.

The primary issues revolved around the inconsistent maintenance and following of written standard operating procedures (SOPs) for the collection, processing, and distribution of blood. Specific findings included SOPs lacking an explicit requirement for retaining donor contact information for eight weeks post-donation. Employees were observed deviating from SOPs and manufacturer instructions during donor phlebotomy, specifically regarding blood tube inversion and blood bag agitation. Additionally, visual inspections of red blood cell units at the labeling stage were not performed as outlined in company procedures. A significant concern was that quality review and approval of validation records for new equipment, such as centrifuges and a blast freezer, were not completed *before* the equipment was placed into operational use, contrary to established validation policies.

Further observations noted a failure to ensure donors adequately reviewed educational materials. An employee was observed marking a donor's questionnaire as compliant despite the donor not reviewing the materials or the medication deferral list. Lastly, the facility failed to obtain confirmation from a donor regarding their contact availability at the provided postal address for eight weeks post-donation. Inova Health Care Services is expected to address these observations with appropriate corrective actions to ensure full compliance with their procedures and FDA regulations.

## 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/806a3f5b-8921-481c-bb0b-aa62a119e06c)

## Related Officers

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

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

Office: https://www.globalkeysolutions.net/offices/department-of-health-and-human-services/cecfcda4-4afa-4a1f-a7b7-a020b79f9861