Creation Technologies LTDMarch 9, 2023

FDA 483 - Creation Technologies LTD - March 09, 2023

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Record Details

An FDA inspection of Creation Technologies LTD in Mississauga revealed significant deficiencies across multiple quality system areas. The firm failed to adequately establish and follow procedures for corrective and preventive actions, control of nonconforming products, change management, and complaint handling. Additionally, software used in production for device label printing was found to be unvalidated.

Company: Creation Technologies LTD
Inspection Date: March 9, 2023
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Maryam Tabatabaie (issuing_officer)

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ID · d2625414-62be-41e6-bbe4-3efcd33ae6b9