Biocompatibles Inc. – FDA Warning Letter, Apr 3, 2013

The FDA inspected Biocompatibles, Inc. from February 26 to April 3, 2013, and found their Patient-Specific Radioactive Brachytherapy Needle Sets adulterated due to non-conformity with the Quality System (QS) regulation (21 CFR Part 820). Key violations included the failure to validate processes (21 CFR 820.75(a)) for prostate needle plug fitting, radioactive seed encapsulation, and Ethylene Oxide sterilization, despite serious complaints of accidental radioactive seed injections and excessive flashing. The firm also failed to analyze all quality data (21 CFR 820.100(a)(1)), specifically by not recording all test data for prostate needle lots, which had potential health hazard implications. Furthermore, Biocompatibles, Inc. did not adequately investigate complaints (21 CFR 820.198(c)) involving device failures, such as seeds being delivered to unintended tissues or getting stuck, without proper risk assessments. Finally, the firm failed to establish adequate environmental control procedures (21 CFR 820.70(c)), evidenced by uninvestigated microbiological excursions in cleanrooms where results were improperly averaged. The FDA deemed the firm's April 22, 2013, response largely inadequate, requiring prompt and comprehensive corrective actions within fifteen business days, including documentation and a timetable. Failure to comply could result in severe regulatory actions, including seizure, injunctions, civil money penalties, and impact on federal contracts and device approvals. The firm was also reminded to review its Medical Device Reporting (MDR) procedures.