FDA WARNING_LETTER - Manhattan Stitching Company, Inc. - February 11, 2021

On April 13, 2021, the FDA issued a Warning Letter to Manhattan Stitching for offering "KN95 Face Mask," "3-ply Face Mask," and "3-Ply Disposable Youth Face Mask" for sale on their websites and social media, claiming they mitigate, prevent, treat, diagnose, or cure COVID-19.

The FDA determined these products are unapproved devices under the Federal Food, Drug, and Cosmetic Act. They are adulterated under section 501(f)(1)(B) because the firm lacks an approved premarket approval (PMA) or investigational device exemption (IDE). They are also misbranded under section 502(o) for failure to notify the FDA of intent to introduce devices into commercial distribution (510(k) requirement).

Additionally, the KN95 Face Mask is misbranded under section 502(a) due to false or misleading labeling. The website displayed a "Certificate of Registration" from "Shenzhen Huawin Testing Certification Co., Ltd." for the manufacturer, JinJiang Rongxin Maternal and Child Supplies Co., Ltd., which incorporated an unauthorized FDA logo and implied FDA approval, clearance, or endorsement. Despite a small-font disclaimer, this was deemed misleading.

Manhattan Stitching was directed to immediately cease selling these adulterated and misbranded products. They must respond within 15 business days with specific corrective actions, a prevention plan