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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 facility. Read More
Zimmer Biomet’s Warsaw, Indiana orthopedic implant manufacturing facility drew a warning from the FDA for quality violations dating back to 2016 after an April inspection revealed ongoing problems. Read More
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. Read More
Failure to maintain complaints from 2014 to 2017 landed Phoenix, Arizona-based Gergens Orthodontics Lab a Form 483 following a May FDA inspection. Read More
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. Read More