US FDA issues warning letter to Smruthi Organics Limited for data issues
The Us FDA issued a warning letter to Smruthi Organics Limited for deviations from current good manufacturing practice (cGMP) for its active pharmaceutical ingredient (API) facility in Solapur, Maharashtra. Smruthi Organics Limited is a manufacturer of pharmaceutical ingredients, veterinary drugs, drug intermediates and photography developing chemicals etc. FDA inspected the site in Solapur and claimed that the company failed to maintain complete and accurate laboratory test data generated in the course of establishing compliance of APIs to established specifications and standards. FDA noticed that there was no written explanation for deletion events observed on audit trials for standalone high-performance liquid chromatography (HPLC) units, with standard operating procedures (SOPs) not including instructions for the retention of electronic raw data.
The raw data to support the test method validation activities was incomplete and even the calibration and media preparation records were not authenticated. The company also fails to maintain and make available production and control records for currently marketed APIs during inspectional review. Inadequate deviation or failure of the batch to meet its specifications or quality standards was also observed.