Company
GermanyDreve Otoplastik Gmbh, Unna, Germany – FDA Inspections
Inspection records and compliance data for Dreve Otoplastik Gmbh in Unna. 2 FDA inspections on record (2 OAI), 1 Form 483, last inspected September 07, 2017.
Company Profile
This profile covers Dreve Otoplastik Gmbh based in Unna, Germany.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 2
- VAI
- 0
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected August 21, 2014. Last inspected September 7, 2017.
Most cited issue areas
- Document changes, review and approval, communication1 inspection
- Lack of or inadequate procedures1 inspection
- Production processes1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 7, 2017 | OAI | Human Drugs · Drug Quality Assurance | 1027670 |
| August 21, 2014 | OAI | Medical Devices & Rad Health · Compliance: Devices | 894893 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Dreve Otoplastik Gmbh
FEI Number
3003610251
Address
Max-Planck-Str. 31, Unna, Germany
Country
Germany
ID: c04ff831-b4ff-471b-a5b1-036065c6f59a