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Talk to a SpecialistTalk to a SpecialistSun Pharmaceutical Industries Ltd. was cited for significant Current Good Manufacturing Practice (CGMP) violations at its Halol, India facility involving sterile drug products, including failure to establish adequate written procedures to prevent microbiological contamination and inadequate media fill validation that did not accurately simulate commercial aseptic operations for medroxyprogesterone acetate injectable suspension. The FDA found that the company's aseptic process simulations were insufficiently representative of actual commercial manufacturing operations, resulting in adulterated drug products. This amended warning letter, issued in October 2023, replaced an initial warning from December 2022 following an FDA inspection conducted in April-May 2022.