FDA Inspection 1102830 — Quest Diagnostics Nichols Institute
The FDA completed an inspection of Quest Diagnostics Nichols Institute on Sep 23, 2019 in Chantilly, VA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 23, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Chantilly, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12288 | 21 CFR 1271.80(c) | Manufacturer instructions not followed |
| 12311 | 21 CFR 1271.160(b)(1) | Ensuring appropriate core requirements followed |