A month after Dr. Reddy's CEO G.V. Prasad received Warning Letter 320-11-014 in June, he was notified of an FDA import ban for products made at the company's plant in Jiutepec, Morelos, Mexico.
The import ban is "detention without physical examination" of the products, according to the FDA. The agency took the action in light of the fundamental nature of the GMP violations that inspectors found during a November 2010 visit.
The agency made sure Prasad would understand the seriousness of the violations: "Your quality unit has not overseen the controls required under CGMP to properly produce APIs. Your December 1 response stated that you will assess your firm's quality needs by April 30, 2011. A quality unit is a basic requirement to ensure that quality APIs are produced at your facility. Please provide a detailed current assessment of this deficiency."
The warning contains just four counts, one of which involves the QA unit failures. The others are failure to validate the methods used to test APIs, incomplete cleaning validation, and incomplete out-of-spec investigations.