FDA Inspection 943780 — Laboratoire Unither
The FDA completed an inspection of Laboratoire Unither on Sep 15, 2015 in Coutances. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 15, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Coutances (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 1388 | 21 CFR 211.101(d) | Component addition checked by 2nd person |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |