Company
GermanyPro-Med Instruments Gmbh, Freiburg Im Breisgau, Germany – FDA Inspections
Inspection records and compliance data for Pro-Med Instruments Gmbh in Freiburg Im Breisgau. 3 FDA inspections on record, 1 Form 483, last inspected June 22, 2017.
Company Profile
This profile covers Pro-Med Instruments Gmbh based in Freiburg Im Breisgau, Germany.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected June 21, 2012. Last inspected June 22, 2017.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design verification - Lack of or inadequate procedures1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 22, 2017 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1015579 |
| November 6, 2014 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 905154 |
| June 21, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 790986 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Pro-Med Instruments Gmbh
FEI Number
3003923584
Address
BOETZINGER STRASSE 86, Freiburg Im Breisgau, Germany
Country
Germany
ID: bc9526ab-268f-4f3c-82e5-f6f2b0b14394