Company
GermanyStratec Medizintechnik Gmbh, Pforzheim, Germany – FDA Inspections
Inspection records and compliance data for Stratec Medizintechnik Gmbh in Pforzheim. 2 FDA inspections on record, last inspected July 09, 2015.
Company Profile
This profile covers Stratec Medizintechnik Gmbh based in Pforzheim, Germany.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected September 7, 2011. Last inspected July 9, 2015.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Failure to submit1 inspection
- Justification for not reporting1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 9, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 935404 |
| September 7, 2011 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 742745 |
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
Stratec Medizintechnik Gmbh
FEI Number
1000646577
Address
Durlacher Str. 35, Pforzheim, Germany
Country
Germany
ID: 2a37d834-aca3-4a07-9640-ed111c4e8a2e