Drug factory · FDA FEI 3002806801
Dexcel Ltd.
1 Dexcel, Or Akiva, Israel
No problems found at FDA's last inspection, Dec 14, 2022.
No Action Indicated: inspectors found no objectionable conditions.
4 drug inspections on record since 2013: 2 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Donepezil | Makes it, tests it and packages it | Dexcel Pharma Technologies Ltd. | 64239-404 |
| Isosorbide Mononitrate | Makes it | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-178, 23155-519, 23155-628 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Dec 14, 2022 | No problems found | Drug Quality Assurance | — |
| Jul 24, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Feb 16, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 5, 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 24, 2019 inspection
- Control procedures to monitor and validate performance 21 CFR 211.110(a)
Control procedures are not established which of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. - Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity. - 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. - Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Registered with FDA for: analysis; label; manufacture; pack.