Company
AustriaBiegler GmbH, Mauerbach, Austria – FDA Inspections
Inspection records and compliance data for Biegler GmbH in Mauerbach. 3 FDA inspections on record, 1 Form 483, last inspected April 18, 2024.
Company Profile
This profile covers Biegler GmbH based in Mauerbach, Austria.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected January 22, 2015. Last inspected April 18, 2024.
Most cited issue areas
- Design verification - Lack of or inadequate procedures2 inspections
- Lack of or inadequate DHR procedures2 inspections
- Nonconforming product, Lack of or inadequate procedures2 inspections
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 18, 2024 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1236227 |
| June 7, 2018 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1055388 |
| January 22, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 916609 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Biegler GmbH
FEI Number
3005813632
Address
Allhangstrase 18a, Mauerbach, Austria
Country
Austria
ID: a51d97cb-1fbf-47b7-82e7-1cdc6f1fe04d