FDA Inspection 1251186 — L. Perrigo Company
The FDA completed an inspection of L. Perrigo Company on Mar 19, 2025 in Allegan, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 19, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Allegan, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 4302 | 21 CFR 211.56(b) | Written sanitation procedures not followed |