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Quali Controle, Meru, France – FDA Inspections

Inspection records and compliance data for Quali Controle in Meru. 2 FDA inspections on record (2 OAI), 2 Form 483s, 1 warning letter, last inspected December 13, 2024.

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Company Profile

This profile covers Quali Controle based in Meru, France.

FDA Inspection History

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

First inspected September 15, 2017. Last inspected December 13, 2024.

Most cited issue areas

  • Investigations of discrepancies, failures2 inspections
  • Test methods2 inspections
  • Computer control of master formula records1 inspection

FDA inspections (2)

DateResultFDA center(s)Insp. #
December 13, 2024OAIHuman Drugs · Drug Quality Assurance1256932
September 15, 2017OAIHuman Drugs · Drug Quality Assurance1025330
FDA documents

Form 483s (2)

  • Form 483s · December 13, 2024
  • Form 483s · September 15, 2017

Warning Letters (1)

  • Warning Letters · September 15, 2017
People (3)
Djamila Harouaka
Person
Francis Godwin
Person
Lisa R. Hilliard
Person
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Laboratorios Farmaceuticos Rovi S.A.
Front Range Laboratories, Incorporated
Alturas Analytics, Inc
Zennova LLC
RHYZ ANALYTICAL LABS
Company Information

Name

Quali Controle

FEI Number

3002807958

Address

29 Rue Paul Vaillant Couturier, Meru, France

Country

France

ID: 19b64d1b-0417-43f9-ae30-317539756145

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