Company
United StatesLinxens Sweden AB – FDA Inspections
Inspection records and compliance data for Linxens Sweden AB. 1 FDA inspection on record, last inspected November 07, 2024.
Company Profile
This profile covers Linxens Sweden AB.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 0
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
Inspected November 7, 2024.
Most cited issue areas
- Design transfer - Lack of or inadequate procedures1 inspection
- Documentation1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 7, 2024 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1253832 |
FDA documents
Form 483s (1)
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Company Information
Name
Linxens Sweden AB
ID: aba1a039-abb0-4f76-89e5-cdcbe4db976f