In a warning letter issued to Hyderabad-based Sri Krishna Pharmaceuticals FDA once again has come across Data Integrity Issues with another Indian Drug Maker.nnThe FDA issued this warning letter one year after conducting the inspection. Issues reported in this warning letter are now a common feature in all such warning letters i.e. nLack of data audit trails, nDeleted sample data by a quality control analyst and nInadequate computer controls that allowed analysts to manipulate data. nThe warning letter notes this incident to be a repeat violation. Similar observations were seen in an inspection carried out at the same site in 2007. The FDA banned imports of products from this company in August 2015 for violation of GMP’s. Therefore all products i.e. Active Pharmaceutical Ingredients manufactured by this company cannot enter the US.
Sri Krishna Pharmaceuticals Ltd. receives warning letter due to cGMP deviations
Sri Krishna Pharmaceuticals Ltd- Statement Of Non-Compliance With Gmp