FDA 483 - Spectrum Laboratory Products, Inc. - March 12, 2021

An FDA inspection of Spectrum Laboratory Products, Inc. in Gardena, CA, an API Repackager/Relabeler, revealed significant deficiencies. The firm failed to maintain adequate quality system investigation reports for complaints and deviations, and exhibited poor security practices for Quality Control Laboratory instrument software. Additionally, the inspection noted a lack of established written procedures for multiple analytical test methods, with one observation being a repeat from a previous inspection.