FDA Inspection 1192307 — IMI TAMI Institute For Research & Development Ltd
The FDA completed an inspection of IMI TAMI Institute For Research & Development Ltd on Dec 8, 2022 in Kiryat Atta. 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 8, 2022
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Kiryat Atta (Israel)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 4406 | 21 CFR 211.194(a)(2) | Suitability of testing methods verified |