FDA WARNING_LETTER - Molteno Ophthalmic Ltd - December 02, 2009

The FDA issued a Warning Letter to Molteno Ophthalmic Limited following an inspection from November 30 to December 2, 2009, at their Dunedin, New Zealand facility, which manufactures the Molteno 3 Glaucoma Drainage Device. The inspection revealed that the devices are adulterated under section 501(h) of the Act, as manufacturing methods, facilities, or controls do not conform to the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820). Specific violations include failures to establish and maintain adequate procedures for corrective and preventative action (CAPA), including analyzing quality data and investigating nonconformities (21 CFR 820.100(a)(1) and (a)(2)). The firm also failed to adequately validate processes where results cannot be fully verified by subsequent inspection (21 CFR 820.75(a)), establish adequate acceptance procedures for in-process product (21 CFR 820.80(c)), validate device design (21 CFR 820.30(g)), and establish procedures for identifying valid statistical techniques (21 CFR 820.250(a)). Additionally, the devices were found to be misbranded under section 502(t)(2) due to the firm's failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures as required by 21 CFR 803.17. The firm's December 17, 2009 response was deemed inadequate for all observations. Consequently, the devices are subject to refusal of admission into the U.S. (detention without physical examination). Molteno Ophthalmic Limited must provide a written response within fifteen working days detailing specific corrective actions, prevention plans, and a timetable for implementation, with potential re-inspection to verify corrections. Failure to address these issues will impact federal contracts, premarket approvals, and Certificates to Foreign Governments.