Cranial Solutions – FDA Warning Letter, May 14, 2010

An FDA inspection of Cranial Solutions in Pompton Lakes, NJ, from May 5-14, 2010, revealed significant violations of the Quality System (QS) regulation (21 CFR Part 820) for their Cranial Orthosis device, rendering it adulterated under section 501(h) of the Act. The firm received an FDA-483 detailing these objectionable conditions. Key deficiencies included the failure to establish and maintain adequate procedures for corrective and preventive action (21 CFR 820.100(a)), design change control (21 CFR 820.30(i)), and acceptance of incoming product (21 CFR 820.80(b)), the latter being a repeat violation. The firm also failed to maintain device master records (21 CFR 820.181), establish a quality plan (21 CFR 820.20(d) – also a repeat violation), and control required documents (21 CFR 820.40(a)), lacking approval dates and signatures. Furthermore, the facility was not registered as a medical device manufacturer, constituting misbranding under section 502(o) of the Act. Cranial Solutions must promptly correct these violations within fifteen working days, providing a written response detailing corrective actions, preventive measures, and a timetable for completion. Failure to comply may lead to regulatory actions such as seizure, injunction, civil money penalties, and impact federal contracts, premarket approvals, and Certificates to Foreign Governments. The letter emphasizes that the listed violations may indicate broader systemic issues requiring thorough investigation and correction.