FDA WARNING_LETTER - Interojo Inc. - September 27, 2012

An FDA inspection of Interojo, Inc. in Pyeongtaek, South Korea, from September 24-27, 2012, revealed that the firm's manufactured contact lenses, classified as devices, are adulterated under section 501(h) of the Act. This is due to non-conformity with the Quality System regulation (21 CFR Part 820). The inspection identified three significant violations. First, the firm failed to document monitoring and control methods, data, dates, and personnel/equipment for validated processes, as required by 21 CFR 820.75(b)(2). Second, Interojo, Inc. did not establish and maintain adequate procedures for the identification, documentation, validation, review, and approval of design changes before implementation, violating 21 CFR 820.30(i). Third, the firm failed to establish and maintain adequate procedures to control labeling activities, as mandated by 21 CFR 820.120. The firm's October 9, 2012, response to the FDA 483 observations was deemed inadequate for all violations, primarily lacking descriptions and evidence of implemented corrective actions, including comprehensive reviews of previous reports and procedures. Consequently, contact lenses manufactured by Interojo, Inc. are subject to refusal of admission into the U.S. (detention without physical examination) under section 801(a) of the Act. Furthermore, premarket approval applications for Class III devices and Certificates to Foreign Governments will not be granted until these violations are corrected. The firm must provide a written response within fifteen business days detailing specific corrective and preventive actions, including documentation and a timetable for completion, to address these serious quality system deficiencies.