FDAnews Device Daily Bulletin
Medical Devices / Inspections and Audits

Design Controls, Device Master Record Missing at Dallas-Based Mibo Medical

Aug. 29, 2018

Failure to establish design controls, acceptance procedures or a quality policy for its MiBo Thermoflo Class II device landed specification developer and manufacturer Mibo Medical Group a Form 483 following a May inspection of its Dallas, Texas facility.

Marketed since 2014, the device hydrates eyes via an electric heating element that delivers continuous heat to the eyepad, which breaks down hardened lipids.

The firm had not defined, documented or implemented design control procedures that addressed design input, outputs, review, verification, validation or design changes, according to the nine-item 483.

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