Manhattan Stitching Company, Inc.

Warning LetterClosed

Manhattan Stitching Company, Inc. 8362 Artesia Boulevard, Suite E Buena Park , CA 90621 United States katie@manhattanstitching.com abby@manhattanstitching.com cory@manhattanstiching.comIssued Apr 13, 2021Center for Devices and Radiological Health

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations1

Issue DateApr 13, 2021

Product TypeDrugs

StatusClosed

Closeout LetterOct 4, 2021

Letter Details

Firm: Manhattan Stitching Company, Inc.
Location: Manhattan Stitching Company, Inc. 8362 Artesia Boulevard, Suite E Buena Park , CA 90621 United States katie@manhattanstitching.com abby@manhattanstitching.com cory@manhattanstiching.com
FEI Number: N/A
Country: United States
Issue Date: April 13, 2021
Issuing Office: Center for Devices and Radiological Health
Product Type: Drugs
Status: Closed
Closeout Letter: October 04, 2021

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.

Manhattan Stitching Company, Inc. FDA Warning Letter, April 13, 2021