FDA Inspection 1172983 — LEO Pharma Ireland
The FDA completed an inspection of LEO Pharma Ireland on Jun 24, 2022 in Dublin 12. 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 24, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dublin 12 (Ireland)
Citations
| ID | CFR | Description |
|---|---|---|
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3553 | 21 CFR 211.48(a) | Plumbing System Defects |