FDA Inspection 985050 — Owen Biosciences Inc.
The FDA completed an inspection of Owen Biosciences Inc. on September 14, 2016 in Baton Rouge, LA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 14, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Baton Rouge, LA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1927 | 21 CFR 211.166(b) | Accelerated stability studies |
| 3615 | 21 CFR 211.160(b)(4) | Test devices not meeting specifications |
| 4576 | 21 CFR 211.192 | No written record of investigation |