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Medical Devices / Inspections and Audits

FDA Cites Dental Components Over Complaint Investigations

Jan. 9, 2018
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A devicemaker’s manufacturing facility in Oregon was cited for closing customer complaint investigations without documenting the changes identified for addressing the issues or verifying their effectiveness.

An FDA investigator reviewed eight complaints of Dental Components’ distributed medical devices during a September 2017 site inspection and found that four of them listed corrective actions, but their effectiveness had not been documented.

Issues reported in the complaints include a barb coming out of the Autoclavable Premium Saliva Ejector swivel assembly, and threaded tips not screwing off.

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