FDAnews Device Daily Bulletin
Medical Devices / Inspections and Audits

Buffalo’s Graphic Controls Acquisition Fails to Control Product

Sept. 25, 2018
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Devicemaker Graphic Controls Acquisition lacked numerous procedures to ensure that products conformed to specifications, according to a 483 the firm received following a May 8-14 inspection of its Buffalo, New York facility.

Numerous CAPAs reviewed didn’t include an adequate investigation and many didn’t include validation of the effectiveness of the corrective actions taken. The agency investigators noted that complaints describe corrective actions that “are taking place or have taken place,” but CAPAs were not created for the issues identified in the complaints.

The 483 said the firm had not established procedures to control products that did not conform to specified requirements. For example, a number of nonconformances reviewed didn’t include documented evaluation of the need for an investigation and there was no justification for control of nonconforming material.

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