Posted 03 February 2015
By Alexander Gaffney, RAC
In recent months, the US Food and Drug Administration (FDA) has identified more than a dozen Indian pharmaceutical manufacturers who have had problems with the data integrity practices at their respective facilities.
Those data are intended to ensure that products meet pre-established specifications, such as for purity, potency, stability and sterility. In the absence of credible data, the concern is that these products cannot be trusted. And indeed, FDA has subject many of these same companies to import alerts, refusing their products entry into the US.
For a look at the Warning Letters FDA has sent to Indian pharmaceutical manufacturers about data integrity programs, check out the chart below:
Last updated on 3 February 2015