Company
GermanyBernstein AG, Porta Westfalica, Germany – FDA Inspections
Inspection records and compliance data for Bernstein AG in Porta Westfalica. 2 FDA inspections on record, last inspected November 10, 2016.
Company Profile
This profile covers Bernstein AG based in Porta Westfalica, Germany.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected February 26, 2009. Last inspected November 10, 2016.
Most cited issue areas
- Design review procedures - personnel1 inspection
- DMR device specifications1 inspection
- Document review, approval documentation1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 10, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 994375 |
| February 26, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 569728 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Bernstein AG
FEI Number
3003635889
Address
Hans-Bernstein-Str. 1, Porta Westfalica, Germany
Country
Germany
ID: 11527cf1-c60d-47ad-92aa-1a303c8d1e23