FDA WARNING_LETTER - Better Health Systems, Inc - December 12, 2014

On December 10-12, 2014, an FDA inspection of Better Health Systems, Inc. in Monument, CO, identified significant violations regarding their Bio-Soft Oraliner (Self-Cure and Heat-Cure) medical devices. The devices were deemed adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(o).

Key violations include: 1. Failure to establish procedures for complaint handling (21 CFR 820.198(a)) and Medical Device Reporting (MDR) (21 CFR 803.17). 2. Lack of procedures for process controls, specifically for packaging and labeling (21 CFR 820.70(a)). 3. Failure to maintain device history records (21 CFR 820.184). 4. Absence of procedures for supplier evaluation and incoming product acceptance/rejection, including documentation (21 CFR 820.50, 21 CFR 820.80(b)). 5. No procedures for controlling nonconforming product (21 CFR 820.90(a)).