FDA Inspection 1096505 — Dexcel Pharma Technologies - Yokneam Factory
The FDA completed an inspection of Dexcel Pharma Technologies - Yokneam Factory on Jul 17, 2019 in Yokne'Am Ilit. 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
- Jul 17, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Yokne'Am Ilit (Israel)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 3573 | 21 CFR 211.101(b) | Measured components for manufacturing |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |