Drug factory · FDA FEI 3008404887
Dexcel Pharma Technologies - Yokneam Factory
10 Hakidma, Yokneam Illit, Israel
Problems found, fixed voluntarily at FDA's last inspection, Jul 17, 2019.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
3 drug inspections on record since 2013: 2 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Donepezil | Makes it | Dexcel Pharma Technologies Ltd. | 64239-404 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 17, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 6 |
| Feb 25, 2016 | No problems found | Drug Quality Assurance | — |
| May 29, 2013 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jul 17, 2019 inspection
- Measured components for manufacturing 21 CFR 211.101(b)
Components for drug product manufacturing are not measured and subdivided as appropriate. - Control procedures to monitor and validate performance 21 CFR 211.110(a)
Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. - Test methods 21 CFR 211.165(e)
The accuracy, specificity and reproducibility of test methods have not been established and documented. - Batch production and Batch Control Record Requirements 21 CFR 211.188(b)
The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing. - Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration of equipment is not performed according to a written program designed to assure proper performance.
Registered with FDA for: label; manufacture; pack.