FDA 483 - Titronics Research & Development Co. - July 09, 2019

Titronics Research & Development Co. in Tiffin, IA, received a Form FDA 483 following an inspection that revealed significant deficiencies in their quality system. Observations included inadequate implementation of procedures for nonconforming product control, insufficient details in calibration procedures, and a failure to adequately establish and implement document control. Additionally, the firm was cited for not adequately maintaining device history records and for an undefined DHR retention procedure.