FDA 483 - PharmaZell GmbH - September 22, 2017

An FDA inspection of PharmaZell GmbH, an API drug manufacturer in Raubling, Germany, revealed significant deficiencies across its operations. The firm's quality control unit failed to adequately address a high number of deviations, many stemming from human errors, with insufficient corrective actions. Additionally, laboratory controls were found lacking due to incomplete test method validations and a deficient stability program for API drug products, impacting the determination of appropriate expiration dates.