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The clearance expands access to Adherium’s Hailie online system to consumers using Teva’s ProAir HFA and GSK’s Ventolin HFA and Flovent HFA, medications for bronchospasms and asthma. 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