Company
GermanyNordmark Arzneimittel GMBH & Co. KG, Uetersen, Germany – FDA Inspections
Inspection records and compliance data for Nordmark Arzneimittel GMBH & Co. KG in Uetersen. 8 FDA inspections on record, 3 Form 483s, last inspected February 13, 2025.
Company Profile
This profile covers Nordmark Arzneimittel GMBH & Co. KG based in Uetersen, Germany.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 0
- VAI
- 7
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 3
- Warning letters
- 0
First inspected April 9, 2009. Last inspected February 13, 2025.
Most cited issue areas
- Test method modification records not maintained1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 13, 2025 | Not classified | Human Drugs | 1263912 |
| August 31, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1241654 |
| August 16, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1099709 |
| February 17, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1006686 |
| November 20, 2014 | VAI | Human Drugs · Drug Quality Assurance | 907095 |
| November 29, 2012 | VAI | Human Drugs · Drug Quality Assurance | 810090 |
| February 26, 2010 | VAI | Human Drugs · Drug Quality Assurance | 653161 |
| April 9, 2009 | VAI | Human Drugs · Drug Quality Assurance | 580439 |
FDA documents
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Company Information
Name
Nordmark Arzneimittel GMBH & Co. KG
FEI Number
3003293533
Address
Pinnauallee 4, Uetersen, Germany
Country
Germany
ID: 871eb270-8517-4646-923a-b4d2eb0ea73b