FDA WARNING_LETTER - BC Group International, Inc. - November 23, 2010

An FDA inspection of BC Group International, Inc. from November 15-23, 2010, revealed that their Class II medical devices, DA-2006 and DA-2006P Defibrillator Analyzers, 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). Specific CGMP violations include failure to validate processes (21 CFR 820.75(a)), lack of established process control procedures (21 CFR 820.70(a)), and inadequate documentation of design reviews (21 CFR 820.30(e)). Additionally, the devices are adulterated under section 501(f)(1)(B) for lacking an approved premarket approval (PMA) or investigational device exemption (IDE) application. They are also misbranded under section 502(o) for failing to submit a 510(k) premarket notification. The FDA requires prompt corrective action within fifteen business days, including a plan to prevent recurrence and supporting documentation. Failure to comply may result in regulatory actions such as seizure, injunction, civil money penalties, and impact federal contracts, PMA approvals, and Certificates to Foreign Governments.