FDA EIR - QOL Medical LLC - August 30, 2019

An FDA Good Manufacturing Practice (GMP) surveillance inspection was conducted at QOL Medical LLC in Clearwater, FL, from August 27 to August 30, 2019. The inspection focused on the company's manufacturing of Sacrosidase drug substance, a biological product. Operating under the regulatory framework for Human Drug Substances Manufacturers and ICH Q7 guidelines, the inspection identified one significant observation documented on a Form FDA 483. The main violation cited was the firm's failure to properly execute and document preventive maintenance, specifically regarding the justification for not calibrating mixing equipment (impellers/vessels) used in critical drug substance manufacturing steps. These mixing speeds are specified in batch records, indicating a need for calibrated equipment. A verbal observation also noted the unacceptable condition of a dented white paddle used for dispensing raw materials. Previous inspection observations from August 2018 regarding material testing and disinfectant efficacy were found to have been adequately addressed through voluntary corrections. QOL Medical LLC's General Manager was issued the FDA 483 and committed to addressing the paddle issue. The company is required to submit a written response to the FDA 483 observation within 15 business days, outlining its corrective and preventive actions. The FDA warned that uncorrected conditions could lead to legal sanctions under the FD&C Act.