The FDA ensured an Oregon-based maker of nighttime dental devices for sleep apnea and snoring won’t get much sleep after it slammed the company over manufacturing issues.
The agency warned Beaverton, Ore.-based BioModeling Solutions Inc. over various issues relating to dental medical devices promoted for uses in nighttime snoring and Obstructive Sleep Apnea (OSA), including lapses in corrective and preventive action and complaint handling. The agency’s letter to the company was posted online Jan. 23.
Warning letters are often a good indication of the FDA’s enforcement priorities. The FDA frequently cites companies for violating current good manufacturing practice (cGMP) requirements ...
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