Drug factory · FDA FEI 3003831171
Catalent Germany Schorndorf GmbH
Steinbeisstrasse 1-2, Schorndorf, Germany
Problems found, fixed voluntarily at FDA's last inspection, Mar 17, 2022.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
7 drug inspections on record since 2009: 2 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Dabigatran | Packages it and labels it | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0425, 0597-0430, 0597-0435 +3 |
| Dutasteride and Tamsulosin | Makes it | Waylis Therapeutics LLC | 80725-809 |
| Efbemalenograstim Alfa | Packages it and labels it | Acrotech Biopharma Inc | 72893-016 |
| Elinzanetant | Packages it | Bayer HealthCare Pharmaceuticals Inc. | 50419-475 |
| Lanthanum Cation (3+) | Makes it, tests it, packages it and labels it | Takeda Pharmaceuticals America, Inc. | 54092-256, 54092-257 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 17, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 14, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 21, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Oct 26, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 7, 2014 | No problems found | Drug Quality Assurance | — |
| Feb 10, 2012 | No problems found | Drug Quality Assurance | — |
| Sep 3, 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 21, 2018 inspection
- In-Process and Laboratory Control Results 21 CFR 211.188(b)(5)
The batch production and control records are deficient in that they do not include in-process control results.
Registered with FDA for: analysis; label; manufacture; pack.