FDA Inspection 772364 — Inova Health Care Services
The FDA completed an inspection of Inova Health Care Services on February 13, 2012 in Sterling, VA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 13, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Sterling, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 161 | 21 CFR 606.160(a)(2) | Determination of lot numbers and supplies |
| 211 | 21 CFR 640.3(b)(2) | Qualifications of donor - blood pressure |
| 4378 | 21 CFR 211.188(b)(2) | Identity of major equipment and lines used |
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 88 | 21 CFR 606.100(b)(9) | Written methods for investigating adverse reactions |
| 9086 | 21 CFR 600.14(a)(1) | Who must report - manufacturer |
| 98 | 21 CFR 606.100(c) | Thorough investigations |