FDA Inspection 1102739 — COSMOPHARM LTD
The FDA completed an inspection of COSMOPHARM LTD on Sep 19, 2019 in Emek Hefer. 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 19, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Over-the-Counter Drug Evaluation
- Location
- Emek Hefer (Israel)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |