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Sun Pharmaceutical Industries Limited's manufacturing facility in Dadra and Nagar Haveli, India was found in violation of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceutical drugs during an FDA inspection conducted in December 2023. The facility failed to adequately clean and maintain manufacturing equipment, with investigators observing approximately 450 mL of stagnant liquid containing numerous chemical peaks and excessive microbial contamination (too numerous to count colony forming units) in a nondedicated piece of equipment. These failures to properly sanitize and maintain equipment violated 21 CFR 211.67(a) and rendered the drug products adulterated under the Federal Food, Drug, and Cosmetic Act.