FDA Warns Indian Lab for Serious cGMP Violations

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.

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