FDA Inspection 795641 — Bionique Testing Laboratories LLC
The FDA completed an inspection of Bionique Testing Laboratories LLC on July 26, 2012 in Saranac Lake, NY. 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
- July 26, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Saranac Lake, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 3615 | 21 CFR 211.160(b)(4) | Test devices not meeting specifications |