FDA 483 - Azzur Labs - San Diego LLC - August 19, 2022

Azzur Labs - San Diego LLC, a control testing laboratory, received an FDA Form 483 citing significant deficiencies in quality control and laboratory operations. The firm failed to ensure proper review of environmental monitoring calculations and raw data by the Quality Department. Additionally, observations included a lack of scientific justification for decontamination procedures and hold time studies, as well as the use of unqualified equipment for critical processes.