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

Latest Issue
PharmTech

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.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

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

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
27%
Attracting a skilled workforce
27%
Obtaining/maintaining adequate financing
14%
Regulatory compliance
32%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Report: Pfizer Makes $101 Billion Offer to AstraZeneca
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here