General Hearing Instruments Inc – FDA Warning Letter, Aug 15, 2013

The FDA issued a Warning Letter to General Hearing Instruments, Inc. following an inspection from August 12-15, 2013, which found the firm's ready-wear-air conduction hearing aids to be adulterated. The devices were deemed adulterated under Section 501(h) of the Act because their manufacturing, packing, storage, or installation methods did not conform to the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820). Eight significant violations were identified. These include the failure to adequately establish and maintain procedures for: corrective and preventive action (CAPA) (21 CFR 820.100(a)); receiving, reviewing, and evaluating complaints (21 CFR 820.198(a)); and controlling nonconforming product (21 CFR 820.90(a)). The firm also failed to adequately maintain its device master file (21 CFR 820.181), establish procedures for conducting quality audits (21 CFR 820.22), ensure purchased products/services conform to requirements (21 CFR 820.50), and establish design control procedures (21 CFR 820.30(a)). Additionally, the firm failed to adequately develop, maintain, and implement Medical Device Reporting (MDR) procedures (21 CFR 803.17). The FDA noted that several procedures were inadequately integrated into the CAPA procedure. The firm must take prompt action to correct these violations and respond within fifteen working days, detailing specific corrective steps, prevention plans, and a timetable. Failure to comply may result in regulatory actions such as seizure, injunction, civil money penalties, and impact on federal contracts, premarket approvals, and Certificates to Foreign Governments. The identified issues suggest serious systemic problems in the firm's manufacturing and quality assurance.