483
Creation Technologies LTDFDA 483 - Creation Technologies LTD - March 09, 2023
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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.
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