FDA Inspection 1099809 — Norgine Limited
The FDA completed an inspection of Norgine Limited on August 16, 2019 in Hengoed. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 16, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hengoed (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 3611 | 21 CFR 211.160(b)(3) | Acceptance of drug products |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |