FDA Inspection 1005016 — SanUp
The FDA completed an inspection of SanUp on Jan 27, 2017 in Aywaille. 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
- Jan 27, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Aywaille (Belgium)
Citations
| ID | CFR | Description |
|---|---|---|
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |