FDA Warning Letter: Zydus Lifesciences cited for contamination, aseptic processing, and PPQ deficiencies
What happened FDA inspected Zydus Lifesciences Limited in Gujarat from April 15 to 23, 2024, and cited significant CGMP violations involving investigations, aseptic processing, and process validation. FDA stated that multiple cross-contamination events over about three months were linked to inadequate cleaning of shared equipment. Investigations did not cover all potentially affected batches, equipment, product-contact … Read more