FDA WARNING_LETTER - Lusys Laboratories, Inc. - May 15, 2015

The FDA issued a Warning Letter to Lusys Laboratories, Inc. following inspections in January-February and May 2015, identifying significant Current Good Manufacturing Practice (CGMP) violations for its in-vitro diagnostic test kits, including those for Hepatitis, HIV, PSA, and Ebola. The devices are deemed adulterated under 21 U.S.C. § 351(h) due to non-conformity with the Quality System (QS) regulation (21 CFR Part 820), which is also required for legal export.

The inspection revealed 13 major QS deficiencies, including failures to establish and maintain procedures for corrective and preventive actions, process validation, design control, complaint handling, purchasing control, finished device acceptance, environmental controls, contamination prevention, device master records, adequate organizational structure, management review, quality audits, and document control. Furthermore, the devices are adulterated under 21 U.S.C. § 351(f)(1)(B) for lacking approved Premarket Approval (PMA) applications or Investigational Device Exemptions, including Emergency Use Authorization for Ebola devices. They are also misbranded under 21 U.S.C. § 352(o) for failure to submit 510(k) notifications. The firm's responses to the FDA 483 were deemed inadequate, lacking documentation or evidence of implemented corrections. Lusys Laboratories must promptly correct these systemic violations within 15 business days, providing a comprehensive plan and timetable, or face potential regulatory actions such as seizure, injunction, civil penalties, and denial of PMAs or Certificates to Foreign Governments.