The US Food and Drug Administration (FDA) has issued a warning letter to Zydus Lifesciences regarding significant violations of good manufacturing practices at its Jarod plant in Vadodara, Gujarat. Following an inspection from April 15 to 23, 2024, the FDA highlighted the company's failure to adequately investigate contamination issues, including glass particulate in batches of Cyanocobalamin Injection. The letter noted that Zydus's methods and facilities did not conform to current good manufacturing practice (CGMP), resulting in the classification of its products as adulterated. Specifically, the FDA criticized the lack of thorough investigations into discrepancies and cross-contamination events that persisted for three months. Zydus has been urged to follow appropriate procedures to prevent microbiological contamination and validate sterilization processes. The agency's warning indicates a serious need for remediation to ensure compliance and safety in pharmaceutical manufacturing.