Sun Pharma failed to adequately clean and maintain equipment used for drug manufacturing at its Dadra-based manufacturing plant, as per the US Food and Drug Administration (USFDA).
In a warning letter issued to company's Managing Director Dilip Shanghvi on June 18, the US health regulator stated it inspected the plant in the Union Territory of Dadra and Nagar Haveli and Daman and Diu from December 4-15, 2023.
"Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitise and/or sterilise equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements," the USFDA said.
The warning letter summarises significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals at the facility, it stated.
USFDA further noted that the company's investigations
