FDA Inspection 1047718 — Tubilux Pharma Spa
The FDA completed an inspection of Tubilux Pharma Spa on Apr 6, 2018 in Pomezia. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Apr 6, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Pomezia (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |