USFDA Issues Severe Warning to Sun Pharma for CGMP Violations

The US Food and Drug Administration (USFDA) has issued a warning letter to Sun Pharma for significant violations of Current Good Manufacturing Practice (CGMP) regulations at its Dadra-based plant. The letter highlights issues such as inadequate cleaning, maintenance, and sterilization, putting drug safety and quality at risk.

The US Food and Drug Administration (USFDA) has taken a firm stance against Sun Pharma, flagging critical lapses in manufacturing practices at the company's Dadra-based facility. A warning letter dated June 18, addressed to Managing Director Dilip Shanghvi, outlines significant breaches of Current Good Manufacturing Practice (CGMP) regulations.

USFDA inspectors, during their visit from December 4-15, 2023, observed that Sun Pharma failed to clean, maintain, and sterilize equipment properly, creating potential risks to drug safety and quality. The regulatory body emphasized that the firm's investigations into batch discrepancies were insufficient, lacking scientific rigor.

The USFDA also noted recurring violations at other facilities, indicating deeper issues with Sun Pharma's global operations. The agency strongly advised the firm to seek external consultancy to achieve compliance and warned of possible re-inspections and regulatory actions until all deficiencies are resolved.

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