Drug factory · FDA FEI 3002807877
Siegfried Hameln GmbH
Langes Feld 13, Hameln, Germany
Problems found, fixed voluntarily at FDA's last inspection, Aug 29, 2024.
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: 0 with no problems, 6 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Dihydroergotamine | Makes it, tests it, packages it, labels it and sterilizes it | Baxter Healthcare Corporation | 36000-300 |
| Ephedrine | Makes it | Exela Pharma Sciences, LLC | 51754-4200 |
| Foscarnet | Makes it, tests it, packages it and labels it | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-771 |
| Human C1-Esterase Inhibitor | Makes it and tests it | Takeda Pharmaceuticals America, Inc. | 42227-081, 42227-083 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 29, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 1, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 24, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 1, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 25, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Jun 14, 2012 | Serious problems, FDA action | Drug Quality Assurance | — |
| Nov 9, 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.
Jul 25, 2014 inspection
- Records reviewed annually 21 CFR 211.180(e)
Records are not maintained so that data therein can be reviewed at least annually to evaluate the quality standards of each drug product to determine the need for changes in specifications or manufacturing or control procedures. - GMP Training Frequency 21 CFR 211.25(a)
GMP training is not conducted on a continuing basis to assure that employees remain familiar with CGMP requirements applicable to them. - Training--operations, GMPs, written procedures 21 CFR 211.25(a)
Employees are not given training in the particular operations they perform as part of their function.
Registered with FDA for: analysis; label; manufacture; pack; sterilize.