FDA WARNING_LETTER - Glottal Enterprises Inc. - October 18, 2012

An FDA inspection of Glottal Enterprises, Inc. in Syracuse, New York, from October 9-18, 2012, revealed significant violations concerning their Electroglottographs, Nasality Visualization System (NVS), and speech software systems. The firm's devices were found to be misbranded under 21 U.S.C. § 352(t)(2) for failing to furnish required Medical Device Reporting (MDR) information and under 21 U.S.C. § 352(o) for not submitting a 510(k) premarket notification. Additionally, the NVS and speech software systems were deemed adulterated under 21 U.S.C. § 351(f)(1)(B) due to the lack of an approved Premarket Approval (PMA) or Investigational Device Exemption (IDE). Specific deficiencies included the failure to develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17. The inspection also identified several Quality System regulation (21 CFR Part 820) nonconformities, including the failure to establish procedures for corrective and preventive action (21 CFR 820.100(a)), design control (21 CFR 820.30(a)), and complaint handling (21 CFR 820.198(a)). Furthermore, the firm failed to adequately document and maintain acceptance activities as part of the device history record (21 CFR 820.80(e)), a repeat violation from a 2006 inspection. The firm's responses to the FDA 483 were largely deemed inadequate, with some violations unaddressed or lacking sufficient documentation and timelines. Glottal Enterprises must promptly correct these violations, provide a written response within fifteen business days detailing corrective actions, and include a timetable for completion to avoid further regulatory actions such as seizure, injunction, or civil money penalties.