Drug factory · FDA FEI 3002806461
Bayer Healthcare Manufacturing Srl
Via Delle Groane 126, Garbagnate-Milanese, Italy
Problems found, fixed voluntarily at FDA's last inspection, Jul 20, 2023.
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 |
|---|---|---|---|
| Ciprofloxacin | Makes it, tests it, packages it and labels it | Bayer HealthCare Pharmaceuticals Inc. | 50419-754, 50419-758, 50419-773 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 20, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 19, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 16, 2015 | No problems found | Drug Quality Assurance | — |
| Mar 15, 2013 | No problems found | Drug Quality Assurance | — |
| Apr 3, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Apr 3, 2009 inspection
- Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies do not include the conclusions and follow-up. - Complete test data included in records 21 CFR 211.194(a)
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. - Sample identification and other information 21 CFR 211.194(a)(1)
Laboratory records do not include the lot number or other distinctive code of the sample.
Registered with FDA for: analysis; api manufacture; label; manufacture; pack.