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SUPERSONIC IMAGINE, Aix-En-Provence, France – FDA Inspections

Inspection records and compliance data for SUPERSONIC IMAGINE in Aix-En-Provence. 3 FDA inspections on record, last inspected March 07, 2024.

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Company Profile

This profile covers SUPERSONIC IMAGINE based in Aix-En-Provence, France.

FDA Inspection History

FDA inspections
3
OAI
0
VAI
1
NAI
2
Form 483s
0
Warning letters
0

First inspected November 6, 2014. Last inspected March 7, 2024.

Most cited issue areas

  • Design changes - Lack of or Inadequate Procedures1 inspection
  • Evaluation of suppliers, contractors, etc., requirements1 inspection
  • Lack of or inadequate complaint procedures1 inspection

FDA inspections (3)

DateResultFDA center(s)Insp. #
March 7, 2024VAIMedical Devices & Rad Health · Compliance: Devices1232785
July 26, 2018NAIMedical Devices & Rad Health · Postmarket Assurance: Devices1063777
November 6, 2014NAIMedical Devices & Rad Health · Postmarket Assurance: Devices905898
FDA documents

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

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Keri Medical
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Apelem
Company Information

Name

SUPERSONIC IMAGINE

FEI Number

3023269186

Address

Zac De L Enfant, Aix-En-Provence, France

Country

France

ID: 7ce13cd3-ada5-4aac-babb-fc4ecd1282d6

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