The FDA has picked apart the process of a Jubilant solid-dose plant in India and criticized it for repeating mistakes it had been told about in the past.
In a warning letter issued a week ago and just posted, the FDA said the Jubilant Life Sciences plant in Sikanderpur Bhainswal, Uttarakhand, had not thoroughly investigated customer complaints and that its quality-control lab was not testing every batch of a product when one batch failed testing, something management had previously committed to doing.
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.