FDAnews Device Daily Bulletin
Medical Devices / Inspections and Audits

RMS Surgical Cited for Poor Complaint Handling

July 20, 2018

Contract manufacturer RMS Surgical was hit with a Form 483 for failing to properly document complaints at its Memphis, Tennessee facility.

Investigations of complaints regarding medical devices were not documented. Specifically, of the 14 complaints the agency reviewed, five did not have documentation of an investigation or the firm’s reasoning for not launching an investigation.

An additional five complaints had documentation of an investigation, but the investigations were not documented on the required customer complaint form.

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