FDA WARNING_LETTER - KayPENTAX, A Division of PENTAX Medical Company - December 18, 2012

An FDA inspection of KayPENTAX, A Division of PENTAX Medical Company, from November 27 to December 18, 2012, revealed that the firm's Class II medical devices, including biomedical instrumentation for speech, voice, and swallowing disorders, are adulterated and misbranded. The devices are adulterated under Section 501(h) of the Act due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and under Section 501(f)(1)(B) for lacking required premarket approval (PMA) or investigational device exemption. They are also misbranded under Section 502(o) for failure to submit 510(k) premarket notification.

Specific QS regulation violations include failures to establish and maintain adequate procedures for corrective and preventive actions (21 CFR 820.100(a)), maintain adequate complaint files (21 CFR 820.198(a)), document agreements with suppliers and contractors regarding product/service changes (21 CFR 820.50(b)), and establish procedures for identifying valid statistical techniques (21 CFR 820.250(a)). The firm's initial response was deemed inadequate or its adequacy could not be determined. KayPENTAX must promptly correct these violations, provide a written response within fifteen business days detailing corrective actions, and submit supporting documentation. Failure to comply may result in regulatory actions such as seizure, injunction, civil money penalties, and impact on federal contracts or PMA approvals.