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Talk to a SpecialistTalk to a SpecialistCipla Limited's Indore, India manufacturing facility failed to comply with Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceutical drugs, resulting in adulterated drug products. During a February 2023 inspection, the FDA identified failures to thoroughly investigate quality discrepancies and defects in Albuterol Sulfate Inhalation Aerosol batches, including inadequate corrective and preventive actions (CAPAs), as well as failure to submit required Field Alert Reports (FARs) to the FDA within the mandated three working days of discovering significant product changes or deterioration. These violations demonstrated systematic deficiencies in the company's methods, facilities, and controls for manufacturing and quality assurance of distributed drug products.