Drug factory · FDA FEI 3002806518
Boehringer Ingelheim Pharma GmbH and Co. KG
Birkendorfer Strasse 65, Biberach an der Riss, Germany
Problems found, fixed voluntarily at FDA's last inspection, Jul 22, 2022.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
10 drug inspections on record since 2009: 3 with no problems, 7 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Aldesleukin | Makes it and tests it | Iovance Biotherapeutics Inc., Prometheus Laboratories Inc. | 73776-022, 65483-116 |
| Alemtuzumab | Makes it, makes the active ingredient and tests it | Genzyme Corporation | 58468-0200, 58468-0357 |
| Idarucizumab | Makes it, makes the active ingredient, tests it, packages it and labels it | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0197 |
| Spesolimab | Makes it, packages it and labels it | Boehringer Ingelheim Pharmaceuticals, Inc., LEO Pharma Inc. | 0597-0035, 0597-0620, 0597-7705 +3 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 22, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 19, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Aug 15, 2019 | No problems found | Bioresearch Monitoring | — |
| Apr 5, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| May 30, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 19, 2013 | No problems found | Drug Quality Assurance | — |
| Mar 13, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 26, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 28, 2010 | No problems found | Drug Quality Assurance | — |
| May 19, 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 19, 2019 inspection
- SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process control functions. - Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Apr 5, 2019 inspection
- Lab controls established, including changes 21 CFR 211.160(a)
The establishment of laboratory control mechanisms including any changes thereto, are not reviewed and approved by the quality control unit. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Registered with FDA for: analysis; api manufacture; label; manufacture; pack.