FDA Inspection 774547 — Impax Laboratories, LLC.
The FDA completed an inspection of Impax Laboratories, LLC. on March 28, 2012 in Hayward, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 28, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hayward, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 4355 | 21 CFR 211.165(c) | Sampling and testing plans not followed |
| 4576 | 21 CFR 211.192 | No written record of investigation |