Company
GermanyPAR Medizintechnik GmbH & Co. KG, Berlin, Germany – FDA Inspections
Inspection records and compliance data for PAR Medizintechnik GmbH & Co. KG in Berlin. 2 FDA inspections on record, last inspected January 16, 2025.
Company Profile
This profile covers PAR Medizintechnik GmbH & Co. KG based in Berlin, Germany.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected January 21, 2015. Last inspected January 16, 2025.
Most cited issue areas
- DHR documentation of label release {see also 820.184}1 inspection
- Lack of or inadequate process validation1 inspection
- Lack of System for Determining MDR Events1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 16, 2025 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1258485 |
| January 21, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 913845 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
PAR Medizintechnik GmbH & Co. KG
FEI Number
3001744144
Address
Sachsendamm 6, Berlin, Germany
Country
Germany
ID: 7731f9bd-17e8-40bd-a844-28c0fac9c852