FDA WARNING_LETTER - GPC Medical Ltd. - June 22, 2017

An FDA inspection of GPC Medical Limited in New Delhi, India, from June 19-22, 2017, revealed that their manufactured devices, including GPC Bone Plates and Spinal Systems, are adulterated under section 501(h) of the Act. The firm's manufacturing methods, facilities, or controls do not conform to the Quality System regulation (21 CFR Part 820). Key violations identified include: 1) Failure to adequately validate processes (21 CFR 820.75(a)), with specific examples of inadequate validation documentation. 2) Inadequate procedures for finished device acceptance (21 CFR 820.80(d)), lacking documented sampling justification. 3) Inadequate procedures to control labeling activities (21 CFR 820.120), with Device History Records missing label accountability and copies of all label sizes. 4) Failure to maintain Device History Records to demonstrate manufacturing in accordance with the device master record (21 CFR 820.184). The firm's August 1, 2017, response to the FDA 483 was deemed inadequate for all observations, lacking a concrete plan or documentation of corrections. GPC Medical Limited must provide a written response within fifteen business days detailing corrective actions, a prevention plan, and a timetable for implementation. Failure to correct these violations may result in premarket approval applications for Class III devices not being approved and federal agencies being advised, potentially impacting contract awards.