FDA Inspection 1265549 — Owen Biosciences Inc.
The FDA completed an inspection of Owen Biosciences Inc. on March 27, 2025 in Baton Rouge, LA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 27, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Baton Rouge, LA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1922 | 21 CFR 211.166(a)(4) | Testing in same container - closure system |
| 2035 | 21 CFR 211.194(e) | Stability testing records not included |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |