FDA Inspection 702914 — Impax Laboratories, LLC.
The FDA completed an inspection of Impax Laboratories, LLC. on January 21, 2011 in Hayward, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 21, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hayward, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1207 | 21 CFR 211.65(b) | Substances That Come in Contact |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4366 | 21 CFR 211.188(a) | Accurate reproduction included |