In one example, the letter said that the facility had received “numerous complaints for damage to functional coating on pantoprazole delayed release tablets” which could affect dissolution. Its investigation, however, tested tablets with discoloration instead of testing those with considerable enteric coating damage that were more likely to fail.
“Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate,” the agency said, suggesting the company hire an outside consultant for help.
These kinds of concerns are not new to the Indian company. Its sterile injectables plants in Spokane, Washington, and Kirkland, Canada, were cited with warning letters in 2013. The investigation of the Quebec plant was closed out the next year.
Mar 14, 2019