FDA WARNING_LETTER - Aurora Optics Company Inc. - October 16, 2012

An FDA inspection of Aurora Optics Company, Inc. (College Point, NY) from October 11-16, 2012, revealed significant violations concerning the firm's imported and distributed soft contact lenses ("Hollow" and "Aurora"). The devices were found to be misbranded and adulterated. Misbranding violations included failure to furnish required Medical Device Reporting (MDR) information and procedures (21 CFR 803.17), and labeling deficiencies such as missing manufacturer/distributor place of business (21 CFR 801.1(d)) and inadequate directions for use, including warnings and contraindications (Section 502(f)(1)). Adulteration stemmed from non-conformity with Current Good Manufacturing Practice (CGMP) and Quality System (QS) regulations (21 CFR Part 820). Specific QS deficiencies included the absence of procedures for complaint handling (21 CFR 820.198(a)), corrective and preventive actions (21 CFR 820.100(a)), acceptance activities (21 CFR 820.80(a)), and nonconforming product (21 CFR 820.90(a)). Aurora Optics must take prompt corrective action and respond to the FDA within fifteen business days, detailing steps taken, prevention plans, and a timetable for completion. Failure to comply could result in regulatory actions like seizure, injunction, civil money penalties, and impact federal contracts, premarket approvals, and Certificates to Foreign Governments.