Drug factory · FDA FEI 3003583056
Farmea
ZAC D' ORGEMONT 10 RUE BOUCHE THOMAS, Angers Cedex 01, France
Problems found, fixed voluntarily at FDA's last inspection, Dec 1, 2022.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
8 drug inspections on record since 2008: 2 with no problems, 6 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Acyclovir | Makes it, tests it, packages it and labels it | Innocutis Holdings LLC | 68712-049 |
| Phenelzine | Makes it | Parke-Davis Div of Pfizer Inc | 0071-0350 |
| Propranolol | Makes it, tests it and packages it | Eton Pharmaceuticals, Inc. | 71863-132 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Dec 1, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 21, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 1, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 12, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Feb 14, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 15, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 26, 2012 | No problems found | Drug Quality Assurance | — |
| Oct 23, 2008 | 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.
Jun 12, 2015 inspection
- Control procedures to monitor and validate performance 21 CFR 211.110(a)
Control procedures are not established which 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. - Establishment of time limitations 21 CFR 211.111
Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product. - Microbiological testing 21 CFR 211.165(b)
Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration of mechanical equipment is not performed according to a written program designed to assure proper performance.
Registered with FDA for: analysis; label; manufacture; pack.