FDA 483 - Rhodes Technologies - July 27, 2016

An FDA inspection of Rhodes Technologies in Coventry, RI, revealed significant deficiencies in the firm's Quality Unit operations. Observations included failures to identify unknown peaks during residual solvent analysis, inadequate investigation of out-of-specification microbial content results, and multiple failures to adequately investigate deviations related to their stability program. These issues highlight systemic problems in quality control and investigation processes.