Form 483 reveals quality control questions and lack of training at Sun Pharma’s plant in India
The FDA has lifted the covers on another drug manufacturing facility in India recently, revealing several concerns around sanitation and improper controls, among other infractions.
Sun Pharma last month received a Form 483 from the agency, with 10 observations for the facility in Halol, India, a small city in the western portion of the subcontinent.
According to the 483, following an inspection from April 26 to May 9, the FDA identified observations including deficient procedures to prevent microbiological contamination of drugs, as well as deficient aseptic processing areas for monitoring environmental conditions and equipment and utensils not being cleaned or sanitized at appropriate intervals.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.