The US Food and Drug Administration (USFDA) has issued a warning to Sun Pharma for not properly cleaning and maintaining equipment at its Dadra plant. The USFDA inspected the plant in December 2023 and found several problems.
The USFDA’s letter, sent to Sun Pharma’s Managing Director Dilip Shanghvi on June 18, pointed out that the company did not clean and sanitize equipment properly. This failure could lead to drug contamination or changes in the drug’s quality.
The USFDA also noted that Sun Pharma’s investigations into production issues were inadequate. The company did not properly investigate when a batch of drugs failed to meet standards.
This is not the first time Sun Pharma has faced such issues. The USFDA mentioned similar problems at other Sun Pharma facilities. The regulator stated that the company’s management needs to improve oversight and control of drug manufacturing.
The USFDA advised Sun Pharma to hire a consultant to help meet manufacturing standards. It also warned that it might not approve new drugs from Sun Pharma until these issues are fixed. Sun Pharma must respond to the USFDA within 15 working days, detailing how it plans to correct these problems and prevent them from happening again.