Drug factory · FDA FEI 3006974616
Laboratoire Unither
1 Rue De L Arquerie, Coutances, France
Problems found, fixed voluntarily at FDA's last inspection, Oct 22, 2021.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2011: 0 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Cyclosporine | Makes it | Caraco Pharmaceutical Laboratories, Ltd. | 47335-506, 47335-507 |
| Timolol | Makes it | Bausch & Lomb Americas Inc., Bausch & Lomb Incorporated | 82260-496, 24208-498, 24208-499 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 22, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 21, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Sep 15, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Sep 19, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 16, 2011 | Problems found, fixed voluntarily | 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 21, 2018 inspection
- Lab controls established, including changes 21 CFR 211.160(a)
The establishment of laboratory control mechanisms including any changes thereto, are not drafted by the appropriate organizational unit and reviewed and approved by the quality control unit.
Sep 15, 2015 inspection
- Component addition checked by 2nd person 21 CFR 211.101(d)
Each component is not added to a batch by one person and verified by a second person. - Identity Testing of Each Component 21 CFR 211.84(d)(1)
The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist. - Reports of Analysis (Components) 21 CFR 211.84(d)(2)
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without performing at least one specific identity test on each component and establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
Registered with FDA for: analysis; label; manufacture; pack.