FDA Inspection 1295306 — BioReliance Corporation
The FDA completed an inspection of BioReliance Corporation on January 29, 2026 in Rockville, MD. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 29, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Rockville, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3918 | 21 CFR 58.33(a) | Study director: follow study protocol |
| 3920 | 21 CFR 58.33(c) | Study director: unforeseen circumstances |