FDA WARNING_LETTER - OST Medical, Inc. - December 31, 2009

The FDA issued a Warning Letter to OST Medical, Inc. following an inspection from November 23 to December 31, 2009, at their Warwick, RI facility, which manufactures and distributes Sentinel enteral feeding pumps and disposable delivery sets. The inspection determined that the devices are adulterated under section 501(h) of the Federal Food, Drug and Cosmetic Act, as the firm's manufacturing, packing, storage, or installation methods and controls do not conform to the Current Good Manufacturing Practice (CGMP) requirements for medical devices, specifically the Quality System regulation (21 CFR Part 820). Significant systemic violations in the firm's quality management system include failures to: establish procedures for ensuring incoming product conformity (21 CFR 820.50); maintain device history records with acceptance documentation (21 CFR 820.184(d)); review, evaluate, and investigate complaints (21 CFR 820.198(c)); establish complaint handling procedures by a designated unit (21 CFR 820.198(a)); and verify or validate corrective and preventive actions (21 CFR 820.100(a)(4)). OST Medical must take prompt corrective action. This includes submitting an audit certification by an outside expert consultant and CEO certification of corrections by July 27, 2010, with subsequent certifications in 2011 and 2012. The firm must respond within 15 working days detailing corrective steps, prevention plans, and a timetable. Failure to comply may lead to regulatory actions such as seizure, injunction, civil money penalties, and impact federal contracts, premarket approvals, and Certificates to Foreign Governments. The letter also reminds the firm of its obligation to report device corrections or removals (21 CFR 806.10(a)(1)).