The QMN Weekly Bulletin
Medical Devices / Inspections and Audits

Bio-Thesiometer USA Flagged for Complaint Handling, MDR Procedures

April 27, 2018

A Cleveland, Ohio medical device manufacturer drew a Form 483 after the FDA’s January inspection found the firm’s procedures were inadequate.

The investigator observed that the firm’s procedures for receiving, reviewing and evaluating complaints were not fully developed.

The firm’s complaint forms did not document an assessment of the MDR, the contact information of the complainant, the firm’s reply to the complainant, the corrective action taken or whether an investigation is needed.

In addition, the firm lacked written procedures for evaluating and submitting MDRs.

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