FDA Inspection 1248317 — Inova Health Care Services
The FDA completed an inspection of Inova Health Care Services on September 4, 2024 in Sterling, VA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 4, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Sterling, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 15038 | 21 CFR 610.47(a)(3) | Notify Consignees [Collecting Establishment] |
| 15067 | 21 CFR 610.46(a)(1)(B) | Notify Consignees [Collecting Establishment] |
| 15069 | 21 CFR 610.46(a)(3) | Notify Consignees [Collecting Establishment] |
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 18097 | 21 CFR 630.10(h) | Ineligible Donor |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9086 | 21 CFR 600.14(a)(1) | Who must report - manufacturer |