FDA Inspection 742136 — Owen Biosciences Inc.
The FDA completed an inspection of Owen Biosciences Inc. on August 19, 2011 in Baton Rouge, LA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 19, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Baton Rouge, LA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2033 | 21 CFR 211.194(c) | Testing and standardization of standards et. al. |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4325 | 21 CFR 211.110(a) | Control procedures fail to include the following |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |