The FDA hit Indian drugmaker Emcure Pharmaceuticals with a warning letter for failing to fully investigate bacterial growth found during batch testing at its facility in Pune, Maharashtra.
In a Feb. 11-20 inspection, agency investigators found violations similar to those observed during an August 2017 visit. They discovered that Emcure again failed to thoroughly investigate sterility failures of injectable drug batches. Contamination with Lysinbacillus fusiformis was identified on Nov. 24, 2017 and Bacillus cereus was found on June 4, 2018.
The firm’s investigations found the most likely cause for both events was laboratory error and it looked into possible microbial contamination during sterility testing but downplayed potential manufacturing issues. The investigations failed to consider manufacturing causes and didn’t gather enough data to support the conclusions, the agency said.