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Specification developer Blue Belt Technologies failed to submit medical device reports (MDRs) for injuries associated with Smith & Nephew’s Navio tissue protector and bone pins, according to a Form 483 the firm received following an FDA inspection of its Pittsburgh, Pennsylvania facility. Read More
Inadequate design validation and risk analysis tripped up hearing aid maker Magnatone Hearing Aid Corp., during an FDA inspection of its Casselberry, Florida facility. Read More
Inadequate procedures for receiving, reviewing and evaluating complaints as well as other quality system shortfalls were observed during an FDA inspection of contract manufacturer LH Medical’s Fort Wayne, Indiana facility. Read More
Failure to validate reprocessing instructions for its Class II reusable menstrual cups and a host of other quality issues landed Dot International a seven-item Form 483 following an FDA inspection of its Evanston, Illinois facility. Read More
Failure to submit medical device reports to the FDA within the prescribed timeframe and lax complaint handling landed duodenoscope maker Olympus a Form 483 following an FDA inspection of its San Jose, California facility. Read More
One complaint related to a guidewire that stuck to a stent during a cystoscopy procedure, and another involved the failure of a grip that required replacement of the device during surgery. Read More
Failure to validate reprocessing instructions for its Class II reusable menstrual cups and a host of other quality issues landed Dot International a seven-item Form 483 following an FDA inspection of its Evanston, Illinois facility. Read More