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Evolutis SAS, Briennon, France – FDA Inspections

Inspection records and compliance data for Evolutis SAS in Briennon. 1 FDA inspection on record, 1 Form 483, last inspected January 31, 2019.

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Company Profile

This profile covers Evolutis SAS based in Briennon, France.

FDA Inspection History

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

Inspected January 31, 2019.

Most cited issue areas

  • Design changes - Lack of or Inadequate Procedures1 inspection
  • Software validation for automated processes1 inspection

FDA inspections (1)

DateResultFDA center(s)Insp. #
January 31, 2019Not classifiedMedical Devices & Rad Health · Compliance: Devices1079980
FDA documents

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

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Company Information

Name

Evolutis SAS

FEI Number

3004187224

Address

Avenue De La Liberation, Briennon, France

Country

France

ID: 3cecaddf-7be8-46a6-ab9c-9fa059508ac1

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