The FDA is continuing its crackdown on manufacturing infractions. The agency has blocked imports from Claris LifeSciences, the India-based injectables maker that also supplies drugs to a number of pharma companies, including Pfizer. The import alert applies to products made at Claris' main plant in India, Pharmalot reports.
In a warning letter, the FDA took Claris to task for a number of manufacturing violations, including failing to follow up on complaints from customers about IV bags contaminated with fungus and bacteria. According to the agency, the company didn't thoroughly investigate the contamination problems, and it didn't notify contract-manufacturing customers about the problems, either.
The FDA says Claris can't sell products in the U.S. made at the Ahmedabad plant until the agency has verified that the problems are fixed. How long that might be is an open question. The FDA blocked imports from fellow Indian drugmaker Ranbaxy Laboratories in September 2008, and the company still hasn't revamped its plants to the FDA's satisfaction.
- check out the FDA warning letter
- see the Pharmalot post
- get more from Bloomberg
- read the Economic Times article