FDA banned the importation of products manufactured at the Mexican unit of Dr. Reddy’s Laboratories, according to Reuters. The import ban is a result of the company’s failure to correct the violations listed in a June 3, 2011, Warning Letter to the agency’s satisfaction.
FDA inspected the Cuernavaca, Mexico, facility, which manufactures active pharmaceutical ingredients (APIs), on Nov. 8–11, 2010, and found several cGMP violations. In the letter, the agency wrote that Dr. Reddy’s had not validated analytical methods for testing APIs, and that the company’s quality unit was not ensuring that APIs manufactured at the site were in compliance with cGMP and met specifications for quality and purity. In addition, FDA found the firm’s cleaning validation to be incomplete for nondedicated manufacturing equipment. Finally, the agency wrote that the site’s out-of-specification investigations did not include an analysis of all available data.
Dr. Reddy’s responded to FDA’s initial observations by implementing several corrective actions. In the Warning Letter, FDA called the company’s response insufficient and asked for additional data and corrective actions.
“Until all corrections have been completed and FDA has confirmed corrections of the deviations and your firm’s compliance with cGMP, FDA may withhold approval of any new applications or supplements listing your firm as an API manufacturer,” said the letter. “In addition, failure to correct these deviations may result in FDA refusing admission of articles manufactured at Industrias Quimicas Falcon de Mexico, S.A. de C.V. (also known as Dr. Reddy’s Mexico) into the United States.” Dr. Reddy’s acknowledged receipt of the Warning Letter on June 14, 2011.