FDA Inspection 1118943 — Owen Biosciences Inc.
The FDA completed an inspection of Owen Biosciences Inc. on February 14, 2020 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). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 14, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Baton Rouge, LA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1134 | 21 CFR 211.25(b) | Supervisor Training/Education/Experience |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1384 | 21 CFR 211.101(c) | Weighing/measuring/subdividing supervision |
| 2011 | 21 CFR 211.188(a) | Accurate reproduction |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 3582 | 21 CFR 211.105(a) | Identification of containers, lines, equipment |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |