Sun Pharma pulled up by USFDA for manufacturing issues at Dadra facility
Mumbai: Sun Pharma did not sufficiently clean and maintain the equipment used in drug manufacturing at its manufacturing plant in Dadra, according to the US Food and Drug Administration (USFDA).
According to a warning letter sent to the company's Managing Director, Dilip Shanghvi, on June 18, the USFDA conducted an inspection of the facility located 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.
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