FDA Hits Maico Diagnostics on Complaints, Design Review

April 6, 2018

Maico Diagnostics received a Form 483 following an October 2017 inspection for its failure to have a formally designated unit to handle complaints, quality audits and procedures for design review.

Complaints involving possible failure of devices to meet any of their specifications were not reviewed, evaluated or investigated, the 483 said. For example, a number of failures were noted and closed without any investigation or analysis of service records.

The firm’s complaint handling procedures didn’t require that complaints be handled in a uniform and timely manner, and they didn’t require information on whether the device is used for treatment or diagnosis. Complaint procedures didn’t require a unique device identifier or universal product code.

In addition, the written medical device reporting procedures didn’t include an internal system for identifying events that may be subject to MDR requirements.

Finally, the firm had not established procedures to conduct quality audits to be sure it was in compliance with quality system regulations. The 483 noted that Maico had “an extensive backlog of unresolved complaints and servicing records from 2016 to 2017.”

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