Company
GermanyOBERON GmbH Fiber Technologies - Inspection Records
Inspection records and compliance data for OBERON GmbH Fiber Technologies in Wildau. 2 FDA inspections on record, 1 Form 483, last inspected February 06, 2025.
Company Profile
This profile covers OBERON GmbH Fiber Technologies based in Wildau, Germany.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 0
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected October 13, 2017. Last inspected February 6, 2025.
Most cited issue areas
- Nonconforming product control1 inspection
- Production and Process Change Procedures, lack of or Inad.1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 6, 2025 | Not classified | Medical Devices & Rad Health · Compliance: Medical Devices | 1260085 |
| October 13, 2017 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 1028572 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Company Information
Name
OBERON GmbH Fiber Technologies
FEI Number
3011310540
Address
Ludwig-Witthoft-Str. 14, Wildau, Germany
Country
Germany
ID: 06894df9-c4cf-4f84-8e97-a08ef7d1954b