FDA 483 - Owen Biosciences Inc. - February 14, 2020

Owen Biosciences Inc., an OTC drug manufacturer in Baton Rouge, LA, was cited for multiple deficiencies during an FDA inspection. Observations included inadequate employee training, lack of equipment validation and calibration, deficient master and batch production records, improper equipment identification, and issues with raw material weighing and warehousing procedures. These issues indicate significant concerns regarding the firm's quality control and adherence to manufacturing standards.