Tosoh Biosciences, Inc. – FDA Warning Letter, May 27, 2010

An FDA inspection of Tosoh Biosciences, Inc. in Grove City, Ohio, from March 23 to May 27, 2010, revealed significant violations regarding their High Performance Liquid Chromatographs (HPLC), Automated Immunoassay Analyzers (AIA), and associated solutions.

The HLC-723G8 HPLC analyzer, marketed for diabetes diagnosis, was deemed adulterated for lacking an approved premarket approval (PMA) or investigational device exemption (IDE), and misbranded for failure to submit a 510(k) notification. The HLC-723G7 device was also misbranded for failing to report corrections and removals to the FDA, specifically four technical information bulletins and a customer letter regarding retention time parameters, column filter material, peak detection parameters, and result reportability criteria. The firm's response regarding these non-reports was deemed inadequate.

Additionally, the inspection identified nine nonconformities with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820). These included: 1. Failure to investigate complaints involving possible device failures (e.g., CPU board and check valve replacements for HLC723G7). 2. Failure to establish adequate complaint handling procedures, with an inconsistent definition of "complaint" and unaddressed customer communications labeled as "complaints." 3. Failure to adequately analyze service reports using statistical methodology,