FDAnews Device Daily Bulletin
Medical Devices / Inspections and Audits

Houston Devicemaker Hit for Complaint Handling

March 7, 2019
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Houston, Texas device manufacturer Sharps Compliance drew a Form 483 from the FDA after agency inspectors found inadequate complaint handling at the facility.

The Nov. 7-15, 2018 investigation revealed that four complaints were missing complete information on device acquisition efforts, including the dates of attempted product retrievals.

The complaint procedure also lacked clear instructions on how to document an investigation and did not require documenting the rationale for launching or not launching a corrective or preventive action.

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