W.H.P.M, Inc. – FDA Warning Letter, Feb 28, 2022

The FDA inspected W.H.P.M., Inc. from February 7-28, 2022, identifying significant violations regarding their COVID-19 Test Kits. The firm distributed these devices without FDA marketing approval, clearance, or authorization, making them adulterated (21 U.S.C. § 351(f)(1)(B) for lack of PMA/IDE) and misbranded (21 U.S.C. § 352(o) for no 510(k)). This constitutes prohibited acts under 21 U.S.C. § 331(a) and (k). Further, the kits are adulterated under 21 U.S.C. § 351(h) due to non-conformity with cGMP requirements (21 CFR Part 820). Specific Quality System deficiencies include failure to establish adequate procedures for product identification (21 CFR §820.60) and failure to maintain quality system records, such as employee training records (21 CFR §820.186). The firm's response to the FDA 483 was inadequate, with corrective actions still in progress. W.H.P.M., Inc. initiated a voluntary recall and committed to procedural updates. The FDA requires immediate action within 48 hours for COVID-19 product violations and a written response within fifteen business days for Quality System issues, including documentation and timelines. Non-compliance risks legal action, denial of export certificates, and public listing for fraudulent COVID-19 products.