FDA 483 - Quali Controle - September 15, 2017

Qual-Controle & Qual-Controle-C.E.Bac, a control testing laboratory in Meru, France, was cited for significant quality control deficiencies during an FDA inspection. Observations included inadequate investigations of out-of-specification results, a lack of quality assurance oversight in laboratory operations, and unvalidated test methods. The firm also failed to implement proper computer system controls and unjustifiably extended reagent expiration dates.