FDA Inspection 1320972 — Owen Biosciences Inc.
The FDA completed an inspection of Owen Biosciences Inc. on May 15, 2026 in Baton Rouge, LA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- May 15, 2026
- Fiscal Year
- 2026
- 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 |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 4576 | 21 CFR 211.192 | No written record of investigation |