Enhancement Medical, LLC – FDA Warning Letter, Jan 15, 2014

The FDA issued a Warning Letter to Enhancement Medical, LLC, following an inspection from 12/16/13 to 1/15/14 in Wauwatosa, Wisconsin, concerning their "Expression" intranasal splint device. The device was found adulterated under 21 U.S.C. § 351(h) for non-compliance with Quality System regulation (21 CFR Part 820). Violations included inadequate procedures for acceptance activities (21 CFR 820.80(a)), corrective and preventive actions (CAPA) (21 CFR 820.100(a)), and complaint handling (21 CFR 820.198(a)). The firm also failed to document supplier evaluations (21 CFR 820.50(a)(1)) and perform quality audits (21 CFR 820.22).

Furthermore, the device was misbranded under 21 U.S.C. § 352(t)(2). The firm failed to submit a written Report of Correction or Removal (21 CFR 806.10) for a significant product exchange in August 2013 due to adverse events. Inadequate Medical Device Reporting (MDR) procedures (21 CFR 803.17) were also cited. The FDA deemed the firm's 2/4/14 response to the FDA-483 inadequate for several issues. The letter also questioned the firm's claims of "injectable filler" and statements implying FDA "indication for use," which could necessitate premarket approval. Enhancement Medical must correct all violations within 15 business days to prevent regulatory actions, including seizure, injunction, and impacts on future device approvals.