Company
GermanyOculus Optikgeraete GMBH, Wetzlar, Germany – FDA Inspections
Inspection records and compliance data for Oculus Optikgeraete GMBH in Wetzlar. 3 FDA inspections on record, last inspected November 10, 2016.
Company Profile
This profile covers Oculus Optikgeraete GMBH based in Wetzlar, Germany.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected June 24, 2010. Last inspected November 10, 2016.
Most cited issue areas
- Document review, approval by designated individual1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 10, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 998293 |
| September 19, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 853199 |
| June 24, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 675579 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Oculus Optikgeraete GMBH
FEI Number
3002807782
Address
Munchholzhauser Str. 29, Wetzlar, Germany
Country
Germany
ID: 373f5590-2503-46cf-80fa-fe2b4ff19c85