The FDA issued a warning letter to Fresenius Kabi for GMP violations observed at its manufacturing facility in Himachal Pradesh, India, citing a failure to investigate sterility issues.
The FDA noted it had previously warned the company for a similar violation found during a May 2015 inspection.
The agency said the firm failed to properly investigate bacterial growth found in two media canisters during a routine stability test.
According to the company’s investigation, laboratory error was the likely cause of the sterility failure. In its response to the FDA, the firm said an analyst at its facility failed to submerge sterility test samples into a sporicidal solution before moving them between sterility testing rooms, spraying them instead and not ensuring the decontamination of the bottom of the units.