FDA Inspection 895649 — L. Perrigo Company
The FDA completed an inspection of L. Perrigo Company on September 16, 2014 in Holland, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 16, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Holland, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1890 | 21 CFR 211.165(e) | Test methods |