FDA Inspection 1150115 — Quest Diagnostics Nichols Institute
The FDA completed an inspection of Quest Diagnostics Nichols Institute on Aug 30, 2021 in Chantilly, VA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Aug 30, 2021
- Fiscal Year
- 2021
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Chantilly, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12288 | 21 CFR 1271.80(c) | Manufacturer instructions not followed |
| 12443 | 21 CFR 1271.270(d) | Retention time (10 year rules) |