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•Switzerland

Bioptron AG, Neuchatel, Switzerland – FDA Inspections

Inspection records and compliance data for Bioptron AG in Neuchatel. 1 FDA inspection on record, 1 Form 483, last inspected November 01, 2017.

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Company Profile

This profile covers Bioptron AG based in Neuchatel, Switzerland.

FDA Inspection History

FDA inspections
1
OAI
0
VAI
1
NAI
0
Form 483s
1
Warning letters
0

Inspected November 1, 2017.

Most cited issue areas

  • Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
  • DHR content1 inspection
  • Product rework procedures, Lack of or inadequate procedures1 inspection

FDA inspections (1)

DateResultFDA center(s)Insp. #
November 1, 2017VAIMedical Devices & Rad Health · Compliance: Devices1031660
FDA documents

No Form 483s, Warning Letters or EIRs on record.

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Stryker Spine SARL
Anteis Sa
Company Information

Name

Bioptron AG

FEI Number

3013929417

Address

Route Des Gouttes-D'Or 30, Neuchatel, Switzerland

Country

Switzerland

ID: 0725d454-f364-4da2-ba85-600b6e7cddde

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