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Validation and CAPA failures were among quality system failures uncovered during a Feb. 26 to March 1 FDA inspection of Pega Medical’s Quebec facility. Read More
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