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Blue Ortho, Meylan, France – FDA Inspections

Inspection records and compliance data for Blue Ortho in Meylan. 2 FDA inspections on record, last inspected April 11, 2024.

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Company Profile

This profile covers Blue Ortho based in Meylan, France.

FDA Inspection History

FDA inspections
2
OAI
0
VAI
1
NAI
1
Form 483s
0
Warning letters
0

First inspected December 17, 2015. Last inspected April 11, 2024.

Most cited issue areas

  • Design review - documentation1 inspection
  • Investigation of device failures1 inspection
  • Report of Death or Serious Injury1 inspection

FDA inspections (2)

DateResultFDA center(s)Insp. #
April 11, 2024NAIMedical Devices & Rad Health · Compliance: Devices1239273
December 17, 2015VAIMedical Devices & Rad Health · Compliance: Devices952969
FDA documents

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

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Companies with similar regulatory profiles, compliance history, and operations.

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COMPANION SPINE FRANCE SAS
Company Information

Name

Blue Ortho

FEI Number

3008027912

Address

22 Chemin Du Vieux Chene, Meylan, France

Country

France

ID: f453eb0b-a35a-42ad-b685-379313c8385e

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