FDA Inspection 835530 — Quest Diagnostics Nichols Institute
The FDA completed an inspection of Quest Diagnostics Nichols Institute on June 19, 2013 in Chantilly, VA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 19, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Chantilly, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12319 | 21 CFR 1271.160(b)(3) | Actions taken and documented |
| 12371 | 21 CFR 1271.200(a) | Cleaned, sanitized per established schedules |