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The FDA issued Greenwood Village, Colorado-based company LED Technologies a Form 483, after observing poor complaint handling, an inadequate design history file and a failure to conduct trend analyses. Read More
The FDA hit Nashville-based CNMC Company with a Form 483 over inadequate risk analysis and device labeling procedures observed by an agency investigator during a March inspection. Read More
The FDA issued Greenwood Village, Colorado-based company LED Technologies a 483, after observing poor complaint handling, an inadequate design history file and a failure to conduct trend analyses. Read More
The FDA issued a Form 483 to class II device manufacturer Neo Innovations over design controls, medical device reporting and complaint procedures. Read More