Company
Germanyaap Biomaterials, GmbH, Dieburg, Germany – FDA Inspections
Inspection records and compliance data for aap Biomaterials, GmbH in Dieburg. 2 FDA inspections on record (1 OAI), 1 Form 483, last inspected September 06, 2018.
Company Profile
This profile covers aap Biomaterials, GmbH based in Dieburg, Germany.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 0
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected February 27, 2014. Last inspected September 6, 2018.
Most cited issue areas
- Design verification - output does not meet input requirement1 inspection
- DHR - not or inadequately maintained1 inspection
- Lack of System for Event Evaluations1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 6, 2018 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1065580 |
| February 27, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 870164 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
aap Biomaterials, GmbH
FEI Number
3005568854
Address
Lagerstr. 11-15, Dieburg, Germany
Country
Germany
ID: b822d3a1-8ec0-4bd5-8b49-48653c9eae60