FDA WARNING_LETTER - MicroAire Surgical Instruments, LLC - August 22, 2014

An FDA inspection of MicroAire Surgical Instruments, LLC in Charlottesville, VA, from August 11-22, 2014, revealed that the firm's Endotine and Ultratine biodegradable implants are adulterated and misbranded. The devices are adulterated under 21 U.S.C. § 351(h) because manufacturing controls do not conform to the Quality System regulation (21 CFR Part 820). They are misbranded under 21 U.S.C. § 352(t)(2) due to failure to furnish required information under 21 CFR Part 803, the Medical Device Reporting (MDR) Regulation. Key violations include: 1) Failure to establish procedures for process validation (21 CFR 820.75(a)), specifically regarding sterilization process validation for grouped device lines, with the firm's response deemed inadequate. 2) Failure to validate software used in production and the quality system (21 CFR 820.70(i)). 3) Failure to develop, maintain, and implement adequate written MDR procedures (21 CFR 803.17(a)), with both initial and revised procedures lacking essential definitions and instructions for timely reporting. The firm must take prompt action to correct these violations and notify the FDA within fifteen business days, detailing corrective and preventive actions, including documentation and a timetable for any delayed activities. Failure to comply may result in regulatory actions such as seizure, injunction, civil money penalties, and impact on federal contracts. The FDA also encouraged the firm to prepare for the eMDR Final Rule taking effect August 14, 2015.