FDA Inspection 959244 — Buderer Drug Company Inc
The FDA completed an inspection of Buderer Drug Company Inc on January 4, 2016 in Perrysburg, OH. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 4, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Perrysburg, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1433 | 21 CFR 211.42(c)(10)(iii) | Air Supply |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1728 | 21 CFR 211.87 | Retest of approved components/containers/closures |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |