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Medical Devices / Inspections and Audits

Canadian Devicemaker Draws Warning for Inadequate Procedures

Nov. 2, 2018
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Canadian devicemaker Cardiomed drew a warning letter from the FDA for failing to resolve problems the FDA found during a May 28-31 inspection.

For example, it lacked written procedures explaining how validations would be performed, including the testing methods, process parameters and acceptance criteria.

In addition, some of the company’s corrective and preventive action procedures were found to be inadequate. For example, one CAPA failed to address how it would evaluate quality data to determine what further action should be taken.

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