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Talk to a SpecialistTalk to a SpecialistZydus Lifesciences Limited's drug manufacturing facility in Gujarat, India was found to have significant Current Good Manufacturing Practice (CGMP) violations that resulted in adulterated pharmaceutical products. The company failed to adequately investigate contamination events, including multiple cross-contamination incidents over a three-month period where one drug product contaminated other products manufactured on shared equipment due to inadequate cleaning procedures. The firm's investigation was insufficient because it failed to consider all impacted batches, all manufacturing equipment involved, and the adequacy of testing methods used to release contaminated products. Additionally, initial cleaning validation studies did not properly assess whether cleaning methods could effectively remove residues from the contaminating drug product.