FDA EIR - Tandem Diabetes Care, Inc. - November 18, 2016

Tandem Diabetes Care Inc. in San Diego, CA, underwent an FDA inspection from October 31 to November 18, 2016. The inspection encompassed both Class III PMA Postmarket (t:slim G4 insulin pump with DexCom G4 platinum CGM) and Class II 510(k) insulin pump devices, aligning with regulatory frameworks outlined in Compliance Programs 7383.001 and 7382.845. The comprehensive review focused on quality system subsystems, including management, design, corrective and preventive actions (CAPA), and production controls.At the inspection's conclusion, the FDA issued a two-item Form FDA-483, detailing significant deficiencies. The primary violation involved the company's failure to adequately implement document and change control procedures, leading to inaccuracies in work instructions, device master records (BOM), and device history records (DHR). The second issue cited was the inadequate design and construction of the (b) (4) Assembly Line, crucial for manufacturing pump cartridges. The firm's President/CEO committed to correcting these observations and submitting a written response within 15 days. A previous inspection in 2014 had resulted in five observations, with most verified as corrected, but one process control issue remained unresolved.