FDA Inspection 1099009 — Inova Health Care Services
The FDA completed an inspection of Inova Health Care Services on August 7, 2019 in Sterling, VA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 7, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Sterling, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18072 | 21 CFR 630.10(b) | Form and manner of educational material |
| 18093 | 21 CFR 630.10(g)(1) | Proof Of Identity |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |