Advanced OrthoPro, Inc. – FDA Warning Letter, Apr 26, 2012

An FDA inspection of Advanced OrthoPro, Inc. in Indianapolis, IN, conducted from April 16-26, 2012, revealed that their AOI Cranial Remolding Helmets are adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act. The firm's manufacturing, packing, storage, or installation methods and controls were found not to conform with the Quality System (QS) regulation, 21 CFR Part 820. Key violations included the failure to establish and maintain adequate procedures for production process controls (21 CFR 820.70(a)), purchasing controls (21 CFR 820.50), acceptance of incoming product (21 CFR 820.80(b)), complaint handling (21 CFR 820.198(a)), maintaining Device Master Records (DMRs) (21 CFR 820.181(a)), establishing Device History Records (DHRs) (21 CFR 820.184), and ensuring adequate personnel training (21 CFR 820.25(b)). The FDA requires prompt corrective action within fifteen business days, including documentation of corrections and a timetable for systemic actions. Failure to comply may lead to regulatory actions such as seizure, injunction, civil money penalties, and impact on federal contracts, premarket approvals, and Certificates to Foreign Governments. The letter emphasizes that the firm must investigate and correct all underlying quality system issues.