FDA WARNING_LETTER - Health Science Products Inc - January 23, 2014

An FDA inspection of Health Science Products, Inc. (Hueytown, Alabama) from January 9-23, 2014, revealed Class I dental chairs and operative units were adulterated (21 USC 351(h)) due to Quality System (QS) regulation non-conformity (21 CFR Part 820) and misbranded (21 USC 352(t)(2)) for Medical Device Reporting (MDR) regulation non-compliance (21 CFR 803). This inspection followed a 2012 Warning Letter and 2013 meeting on similar issues, and the firm's February 27, 2014, response was deemed inadequate. Key QS violations included failures to establish adequate procedures for corrective and preventive action (21 CFR 820.100(a)), complaint handling (21 CFR 820.198(a)), and ensuring purchased product conformity (21 CFR 820.50). The firm also failed to maintain device history records (21 CFR 820.184), device master records (21 CFR 820.181), and document acceptance activities (21 CFR 820.80(e)). A critical MDR violation was the failure to develop, maintain, and implement written MDR procedures (21 CFR 803.17), with the submitted procedure lacking essential internal systems for event review, investigation, timely transmission, and record-keeping. The FDA requires prompt corrective actions, including a written response within fifteen working days detailing steps and a timetable. The firm must also submit certification by an outside expert consultant of a quality systems audit by February 1, 2015, along with CEO certification, and subsequent certifications in 2016 and 2017. Non-compliance could lead to regulatory actions like seizure, injunction, civil money penalties, and impact federal contracts, premarket approvals, and Certificates to Foreign Governments.