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MDR, CAPA Procedures Net Dental Instruments Maker Form 483

February 3, 2020

Failure to develop written medical device reporting procedures, complaint handling procedures, corrective and preventive action procedures landed devicemaker Health Science Products in hot water with the FDA following an inspection of its Hueytown, Alabama facility. 

The dental instrument manufacturer lacked CAPA procedures that include an analysis of the sources of quality data, investigations of causes of nonconformities, identification of the actions needed to prevent the recurrence of nonconforming product or validation of corrective actions, the agency said.

The inspection found that the firm didn’t maintain complaint files and it hadn’t established written complaint handling procedures.

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