FDA Inspection 960408 — NATURA BISSE INTERNATIONAL SA
The FDA completed an inspection of NATURA BISSE INTERNATIONAL SA on Jan 29, 2016 in Cerdanyola Del Valles. 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
- Jan 29, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cerdanyola Del Valles (Spain)
Citations
| ID | CFR | Description |
|---|---|---|
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |