Shenzhen Weifa Technology Co., Ltd Warning Letter Details

Summary

Shenzhen Weifa Technology Co., Ltd was cited for selling FFP1 3-ply masks and N95/FFP2 respirators in the United States without required FDA premarket approval (PMA), investigational device exemption (IDE), or 510(k) clearance, making the products adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act. The company failed to notify FDA of its intent to introduce these devices into commercial distribution and made false claims on its website (starkit.com) that the products were "FDA certificated," despite lacking any such authorization or approval. These violations occurred during the COVID-19 pandemic period when mask and respirator demand was critical, and the company's labeling misrepresentations directly contradicted the absence of any legitimate FDA clearance or registration status.