Drug factory · FDA FEI 3003293533
Nordmark Pharma GmbH
Pinnauallee 4, Uetersen, Germany
Problems found, fixed voluntarily at FDA's last inspection, Feb 13, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
8 drug inspections on record since 2009: 0 with no problems, 8 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Pancrelipase Amylase and Pancrelipase Lipase and Pancrelipase Protease | Makes it, makes the active ingredient and tests it | Vivus LLC | 62541-401, 62541-402, 62541-403 +3 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 13, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 31, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 16, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 17, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 20, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Nov 29, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 26, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 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.
Nov 20, 2014 inspection
- Test method modification records not maintained 21 CFR 211.194(b)
Complete records are not maintained of any modification of an established method employed in testing.
Registered with FDA for: analysis; api manufacture; label; manufacture; pack.