Creation Technologies LtdMarch 5, 2020

FDA 483 - Creation Technologies Ltd - March 05, 2020

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An FDA inspection of Creation Technologies LP in Burnaby, British Columbia, revealed significant deficiencies in their quality system. The firm's procedures for handling customer complaints, controlling nonconforming product, and implementing corrective and preventive actions were found to be inadequate. Additionally, the company failed to adequately establish procedures for ensuring purchased products and services conform to specified requirements.

Company: Creation Technologies Ltd
Inspection Date: March 5, 2020
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Michelle J. Glembin (investigator)

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ID · 81d485a7-96c6-4ce2-80d7-fdfa053feecd