Mahendra Chemicals On FDA Import Alert List
The FDA has issued warning letters blasting any number of Indian API and drugmakers for not carefully testing drugs or sometimes fabricating test results of batches of their products that they shipped to the U.S. Now the agency has sent a warning letter to an Indian contractor some companies rely on for product testing and analysis, noting repeat violations of GMP standards.
FDA actions taken against Indian drugmakers have grabbed a lot of attention in recent years, but Europe has also been pushing foreign suppliers to hit higher standards. Each country does its own inspections but then shares any issues it finds through a common website. Most recently, Italy flagged problems with three plants, two in China and one in India.
Mahendra Chemicals receives Warning USFDA letter for GMP violations