Company
GermanyWaldemar Link GmbH & Co. KG (Mfg Site), Norderstedt, Germany – FDA Inspections
Inspection records and compliance data for Waldemar Link GmbH & Co. KG (Mfg Site) in Norderstedt. 5 FDA inspections on record, 1 Form 483, last inspected February 19, 2026.
Company Profile
This profile covers Waldemar Link GmbH & Co. KG (Mfg Site) based in Norderstedt, Germany.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 3
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected September 16, 2010. Last inspected February 19, 2026.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Environmental control Lack of or inadequate procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 19, 2026 | Not classified | Medical Devices & Rad Health | 1310346 |
| May 11, 2023 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1206902 |
| January 22, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 911197 |
| July 26, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 792790 |
| September 16, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 696404 |
FDA documents
Form 483s (1)
People (1)
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Company Information
Name
Waldemar Link GmbH & Co. KG (Mfg Site)
FEI Number
3003386935
Address
Oststr. 4-10, Norderstedt, Germany
Country
Germany
ID: 276b3518-f8e5-4cd7-9393-883b837c46ce