November 9, 2021
December 14, 2022
|By Megan McGregor
FDA investigators issued a 29-page 483 Report to Rodney Mell, Head of Quality at Philips Respironics, which is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.