Drug factory · FDA FEI 3002808086
Bayer AG
Mullerstr. 178, Berlin, Germany
Problems found, fixed voluntarily at FDA's last inspection, Jun 6, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
9 drug inspections on record since 2010: 4 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Dienogest and Estradiol | Tests it, packages it and labels it | Bayer HealthCare Pharmaceuticals Inc. | 50419-409 |
| Drospirenone and Ethinyl Estradiol | Packages it and labels it | Bayer HealthCare Pharmaceuticals Inc. | 50419-402, 50419-405 |
| Drospirenone and Ethinyl Estradiol and Levomefolic Acid | Packages it and labels it | Sandoz Inc. | 0781-4075 |
| Gadolinium Cation (3+) | Makes it, makes the active ingredient, tests it, packages it, labels it and sterilizes it | Bayer HealthCare Pharmaceuticals Inc. | 50419-325 |
| Gadoquatrane | Makes it, tests it, packages it and labels it | Bayer HealthCare Pharmaceuticals Inc. | 50419-321, 50419-322, 50419-323 +8 |
| Iopromide | Makes it, tests it, packages it, labels it and sterilizes it | Bayer HealthCare Pharmaceuticals Inc. | 50419-342, 50419-344, 50419-346 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 6, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 27, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 24, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Jan 24, 2017 | No problems found | Drug Quality Assurance | — |
| May 13, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Apr 17, 2014 | No problems found | Bioresearch Monitoring | — |
| Sep 18, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 19, 2010 | No problems found | Drug Quality Assurance | — |
| Nov 16, 2010 | No problems found | Bioresearch Monitoring | — |
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 24, 2019 inspection
- Cleaning System 21 CFR 211.42(c)(10)(v)
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions. - Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. - 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.
May 13, 2014 inspection
- Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure that in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity. - Extent of discrepancy, failure investigations 21 CFR 211.192
Investigations of an unexplained discrepancy and 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. - Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.
Registered with FDA for: analysis; api manufacture; label; manufacture; pack; sterilize.