Marcia G Evans

Marcia puts a strong emphasis on adherence to the internal procedures of a firm. She scrutinizes the documentation practices, timely closure of CAPAs, reporting of device deficiencies and investigation of complaints. She takes note of any missing details in documentation and any delays in the processes.

Marcia G Evans is a focused, detail-oriented FDA auditor who takes a keen interest in how firms document their corrective and preventative actions (CAPAs) and complaint files. She emphasizes adherence to internal procedure timeframes and thoroughness in investigation details and justifications for extensions. She also emphasizes on immediate reporting of product deficiencies and expects exhaustive investigations of complaints. Incorrect evaluations of device malfunctions and delays in reporting complaints appear to attract her attention.