The USFDA issued a warning to Sun Pharma’s Managing Director, Dilip Shanghvi, highlighting significant violations at the company’s Dadra manufacturing plant. Inspections from December 4-15, 2023, revealed inadequate cleaning and maintenance of equipment, risking contamination of drug products. The USFDA criticized Sun Pharma’s investigations into out-of-specification results, citing a lack of scientific rationale. Similar CGMP violations were noted at other Sun Pharma facilities, prompting the USFDA to recommend hiring a consultant to meet CGMP standards.