Manhattan Stitching Company, Inc. Warning Letter Details

Summary

Manhattan Stitching Company marketed KN95 face masks and 3-ply face masks as medical devices intended to prevent, mitigate, or treat COVID-19 without FDA authorization, making them adulterated and misbranded products. The company's websites and social media pages contained claims about respiratory protection, filtering harmful particles, and referenced CDC recommendations for face mask use during the COVID-19 pandemic, establishing the products' intended use as disease prevention devices. These marketing statements violated FDA regulations by presenting unapproved medical devices to consumers without proper regulatory clearance or approval.