FDA WARNING_LETTER - Shoney Scientific India - July 05, 2013

An FDA inspection of Shoney Scientific India in Pondicherry, India, from July 2-5, 2013, revealed significant violations of the Quality System (QS) regulation (21 CFR Part 820) for devices including Disposable Biopsy Punches, Dermal Curettes, Liposuction Cannulas, Cervical Dilators, and Tongue Cleaners. The firm's devices are deemed adulterated under section 501(h) of the Act due to non-conformity with good manufacturing practices. Specific QS violations include failure to validate processes (21 CFR 820.75(a)), establish procedures for monitoring validated process parameters (21 CFR 820.75(b)), routinely calibrate and maintain equipment (21 CFR 820.72(a)), and establish training procedures for personnel (21 CFR 820.25(b)). Furthermore, the Disposable Biopsy Punch is adulterated under section 501(f)(1)(B) because the firm lacks an approved premarket approval (PMA) application or investigational device exemption. It is also misbranded under section 502(o) for being introduced into interstate commerce with an intended use different from a legally marketed device (21 CFR 872.4565) without submitting a premarket notification (510(k)) as required by section 510(k) and 21 CFR 807.81(b). The FDA requests the firm immediately cease activities leading to adulteration or misbranding of the Disposable Biopsy Punch. The devices are subject to refusal of admission into the U.S. (detention without physical examination). Shoney Scientific India must provide a written response within fifteen business days detailing corrective actions, prevention plans, and a timetable for completion, including documentation. Failure to correct violations will impact federal contracts and PMA approvals.