Quality shortcomings including rusty equipment and data integrity lapses drew a warning letter from the FDA for GPT Pharmaceuticals’ facility in Hyderabad.
An agency inspection revealed that the firm’s quality unit didn’t properly investigate out-of-specification results for residual solvents. The unit also failed to validate test methods used to find impurities.
The agency also found that employees were able to anonymously end testing runs on high-performance liquid chromatography (HPLC) equipment. Audit trails from HPLC instruments showed a trend of aborted runs. Employees logged in anonymously “with full administrative privileges, to abort HPLC testing runs without [it] being attributable to a specific individual,” the agency said.