FDA WARNING_LETTER - OraWell USA - August 05, 2011

The FDA inspected OraWell USA, owned by Mr. Gerald R. Austin, at its Philadelphia facility on June 29 and August 5, 2011, regarding the manufacture of OraWell Usa? HIV 1/2 Antibody Saliva Rapid Screen Test kits, which are Class III in vitro diagnostic devices. The inspection revealed significant violations. The firm failed to obtain marketing approval or clearance for its HIV test kits before offering them for sale, rendering the devices adulterated under section 501(f)(1)(B) of the Act due to the absence of an approved Premarket Approval (PMA) or Investigational Device Exemption (IDE). Additionally, the devices were misbranded under section 502(o) for failing to submit a 510(k) premarket notification. Furthermore, the inspection found that the firm's manufacturing methods and controls were not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System Regulation (21 CFR Part 820), leading to adulteration under section 501(h) of the Act. The firm reportedly does not adhere to the QS Regulation in any manner. OraWell USA was instructed to promptly correct all violations and respond within 15 working days with a detailed plan and documentation. Failure to comply could result in regulatory actions such as seizure, injunction, or civil money penalties, and impact future contract awards or device approvals. The firm's attorney indicated they would cease manufacturing OraWell USA products.