Indian Drugmaker USV Slammed With FDA 483
September 23rd, 2013 // 1:23 pm @ jmpickett
FDA is accusing Mumbai, India drugmaker USV of faking and fudging data, according to a 483 that stemmed from a June inspection of its laboratory.
FDA stated in the 483 that the drug product testing for validation data is falsified.
USV is one of the top drugmakers in India, and is the third manufacturer in India to be accused of falsifying data. In the other cases, FDA has sent out serious FDA warning letters to Ranbaxy Laboratories, Wockhardt and Posh after inspections of their plants. USV has not gotten a warning letter yet; all they have to this date is the 483 observations. One difference with this case is that FDA found the cGMP violations in the testing labs of the company, while in the other cases, there were cGMP violations with the manufacturing centers.
FDA stated in the 483 that based upon the inspector’s findings and the lab analyst’s statement, there was no assurance that the sample/standard weight values were at all representative of the real weights. It stated that analytical balance clocks were modified so as to come up with faked weight print outs, which appeared to be printed at the exact same time as the sample weighting.
FDA also slapped USV for not doing proper staff training on cGMPs. The president of the company, Debabrata Gupta, stated that the firm expected this issue to be resolved soon.
