FDA Inspection 1210216 — Sentara Enterprises dba Sentara Infusion Services (Blue Ridge)
The FDA completed an inspection of Sentara Enterprises dba Sentara Infusion Services (Blue Ridge) on July 14, 2023 in Charlottesville, VA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 14, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Charlottesville, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22741 | FDCA 501(a)(2)(A) | Personnel exposure during aseptic manipulations |
| 22744 | FDCA 501(a)(2)(A) | Personnel, blocked or disrupted first air |
| 22761 | FDCA 501(a)(2)(A) | Lack of disinfection, equipment/supplies from lower to higher quality air |
| 22766 | FDCA 501(a)(2)(A) | Inadequate smoke studies |
| 22769 | FDCA 501(a)(2)(A) | Media fills, failure |