The QMN Weekly Bulletin
Pharmaceuticals / GMPs

FDA Warns Indian Lab for Serious cGMP Violations

Feb. 28, 2014

A control laboratory testing facility in Mumbai, India, has come under fire from the FDA after a summer inspection last year raised serious concerns about the quality of drugs tested there.

According to a Feb. 6 warning letter, USV Limited failed to properly follow and document required laboratory control mechanisms during the June 7-11 inspection. Specifically, the investigator found sample weights used to measure compounds and test for impurities were falsely created.

“The analyst admitted that the sample weights that were represented as raw data from the analysis actually were backdated balance weight printouts produced after the analysis and generated for the notebooks,” the warning letter says. The failure happened despite USV’s commitment in 2009 to audit all analytical method validations.

The FDA also rapped the company for failing to maintain proper controls over its computer systems to assure that only authorized personnel could make changes to master production and control records. Instead, personnel shared login names and passwords and had the ability to change or delete data, the letter says.

The FDA has some of the most stringent GMP regulations in the world. Are you ready if an inspector knocks at your door?

You can be. Register today for the March 19 training session: Beyond GMP Training: From Training to Learning — Improving GMP Performance.

Through a series of hands-on exercises, you'll develop and deliver a clear and concise GMP training program that will fully prepare your employees to handle GMP with confidence. Don’t dillydally, register now.