With the satisfactory closure of observations in the warning letter and the lifting of the import alert, Dr. Reddy’s can start importing products to the US from the facility, which produces intermediates and active pharmaceutical ingredients.
The FDA inspected the Mexico facility in November 2010 and shared a warning letter on 14 June 2011 with the company.
As the company worked with the regulatory body in resolving the observations in the warning letter, the last inspection report indicated that all of them were satisfied with the outstanding action points that Dr. Reddy’s has submitted.