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The FDA cited Advanced Monitored Caregiving after a March inspection of the devicemaker’s New York facility turned up problems with procedures for device acceptance and evaluation of potential suppliers. Read More
The FDA hit six U.S. devicemakers with 483s for problems agency investigators observed in facility inspections including inadequate risk procedures, labeling and complaint handling. Read More
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