Indian generics maker Dr Reddy's Laboratories has run afoul of FDA's manufacturing standards at a Mexican facility that's key to its operations in that country--and to its supplies for the U.S. market. The agency issued a warning letter to Dr Reddy's about those manufacturing violations, saying that failure to correct them may prompt FDA to bar imports from that plant.
The company says it's working with FDA and formulating a response to the warning letter's citations. The plant in question--in Cuernavaca, Mexico, near Mexico City--was cited for failing to validate API testing methods. Some adulterated APIs may have made their way onto the U.S. market, the agency said.
"If you wish to continue to ship APIs to the United States, it is the responsibility of your firm to ensure compliance with all U.S. standards for [good manufacturing practices] and all applicable U.S. laws and regulations," the FDA said in its letter (as quoted by Reuters).
Dr Reddy's is just the latest India-based generics firm to run into trouble with FDA. Ranbaxy Laboratories has been in hot water at the agency at least since 2009, when violations at its Paonta Sahib, India, plant prompted an import alert and a halt on approval applications, Reuters reports. Aurobindo Pharma fell under its own import ban a few months ago. And Claris LifeSciences is working to sort out some longstanding regulatory problems as well.
Special Report: Dr. Reddy's - Top 10 Generic Drug Companies 2010