FDA 483 - PharmaZell GmbH - September 22, 2017
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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.
ID · 06be9ec5-429c-4b6a-a924-9fc73776de4e