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Medical Devices / Inspections and Audits

FDA Inspection Finds Germany’s Meluna Falls Short on Quality Standards

Sept. 11, 2018
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German menstrual cup maker Meluna fell short on medical device reporting, complaint handling, and CAPA procedures, the FDA said in a six-item Form 483 following an inspection of the firm’s Haundorf, Germany facility.

The firm’s MDR procedure didn’t include an internal system for timely and effective identification and evaluation of events. For example, the firm’s device reporting SOP didn’t include adequate definitions and timelines to ensure timely submission of events subject to MDR requirements, the agency said.

The facility’s procedures for handling complaints were found lacking because they didn’t require information such as the name, address and phone number of the complainant, the date the complaint was received, the lot or serial number of the device and dates and results of investigations.

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