Drug factory · FDA FEI 3002808091
Bayer Weimar GmbH und Co. KG
Döbereinerstrasse 20, Weimar, Germany
Problems found, fixed voluntarily at FDA's last inspection, Nov 24, 2022.
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 2009: 2 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Dienogest and Estradiol | Makes it and tests it | Bayer HealthCare Pharmaceuticals Inc., Sandoz Inc. | 50419-409, 0781-4110 |
| Drospirenone and Ethinyl Estradiol | Makes it and tests it | Bayer HealthCare Pharmaceuticals Inc. | 50419-402, 50419-405 |
| Drospirenone and Ethinyl Estradiol and Levomefolic Acid | Makes it and tests it | Sandoz Inc. | 0781-4075 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 24, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 13, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Nov 5, 2015 | No problems found | Drug Quality Assurance | — |
| Oct 19, 2012 | No problems found | Drug Quality Assurance | — |
| Dec 4, 2009 | 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.
Sep 13, 2019 inspection
- Extent of discrepancy, failure investigations 21 CFR 211.192
Investigations of a failure of a batch or any of its components to meet any of its specifications did not extend to other drug products that may have been associated with the specific failure or discrepancy. - Top/Middle/Bottom container sampling 21 CFR 211.84(c)(4)
Sampling procedures are deficient regarding sampling components from the top, middle, and bottom of container. - Establish reliability of supplier's C of A 21 CFR 211.84(d)(2)
Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.
Registered with FDA for: analysis; manufacture.