FDA 483 - Consumer Product Partners, LLC - November 07, 2022

Vi-Jon, LLC in Smyrna, TN, a manufacturer, was inspected from October 31 to November 7, 2022. The inspection revealed significant deficiencies in the firm's quality control unit, specifically regarding the timely completion of out-of-specification investigations for stability testing and the failure to initiate investigations for out-of-specification microbiology incubator temperatures. These issues indicate a lack of adherence to established procedures and a breakdown in quality oversight.