FDA WARNING_LETTER - Sutures India Pvy. Ltd. - April 23, 2010

An FDA inspection of Sutures India Pvt. Ltd. in Bangalore, India, from April 19-23, 2010, found that the firm's manufactured sutures, classified as medical devices, were adulterated under section 501(h) of the Act. This was due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820). The firm failed to respond to the FDA 483 observations. Key violations included inadequate procedures for design control (21 CFR 820.30(a)(1)), process validation (21 CFR 820.75(a)), equipment maintenance and documentation (21 CFR 820.70(g)(2)), and document control (21 CFR 820.40(a)). Furthermore, the firm failed to maintain adequate Device Master Records (DMRs) (21 CFR 820.181(c)) and establish Device History Record (DHR) procedures (21 CFR 820.184). The devices were also deemed misbranded under section 502(t)(2) of the Act for failing to provide required information under section 519 of the Act and 21 CFR Part 803 (MDR regulation). Consequently, the firm's sutures are subject to refusal of admission into the U.S. (detention without physical examination). Federal agencies, premarket approval applications, and Certificates to Foreign Governments will be impacted. The firm must provide a written response within fifteen working days detailing corrective actions, prevention plans, and a timetable, followed by a required follow-up inspection.