FDA Inspection 1082694 — Tepnel Pharma Services Limited
The FDA completed an inspection of Tepnel Pharma Services Limited on March 11, 2019 in Glasgow. 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: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 11, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Glasgow (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 |
| 4418 | 21 CFR 211.42(b) | Adequate space lacking to prevent mix-ups and contamination |