FDA Inspection 935714 — Teva Pharmaceutical Industries
The FDA completed an inspection of Teva Pharmaceutical Industries on Jun 22, 2015 in Jerusalem. 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
- Jun 22, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Jerusalem (Israel)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |