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Talk to a SpecialistTalk to a SpecialistWintech Medipro LLC, a manufacturer of surgical masks marketed under three ASTM level designations, was found to be distributing adulterated medical devices without an approved Premarket Approval (PMA) application or Investigational Device Exemption (IDE), in violation of section 501(f)(1)(B) of the Federal Food, Drug, and Cosmetic Act. The FDA inspection (June 22–July 6, 2022) identified product labeling and website claims indicating the masks were intended to protect against respiratory illnesses including COVID-19 and influenza, thereby establishing them as medical devices subject to premarket approval requirements that the company had not obtained. The company's failure to secure required regulatory clearance before commercializing these respiratory protective devices represented a significant compliance gap in Current Good Manufacturing Practice (CGMP) and Quality System Regulation (QSR) requirements.