FDA Bans Import of Drugs from Dr. Reddy's Mexico Site - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

FDA Bans Import of Drugs from Dr. Reddy's Mexico Site

ePT--the Electronic Newsletter of Pharmaceutical Technology

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.


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here