The FDA sent another warning to an Intas Pharmaceuticals plant in India, where investigators imposed import bans in late 2022 after finding shredded quality control documents doused in acid.
In early May, the FDA visited Intas' drug manufacturing facility in Ahmedabad, India, to inspect whether improvements were made from previous visits. In a Nov. 21 letter sent to the drugmaker and published to the FDA's website Nov. 28, the agency said it discovered inadequacies and a lack of oversight and repeated infractions of drug quality practices.
Since 2021, there was an "egregious pattern of recording and altering defect counts" at the plant to keep batches within rejection limits, the FDA said. Intas is working with a third party to investigate its data integrity issues, but the regulator said the company failed to share a corrective and preventive action plan.
"You failed to initiate or conduct adequate investigations into significant deviations in your aseptic processing manufacturing operations," the FDA said in its warning letter. "When investigations were conducted, they were often insufficient and lacked scientifically supported root cause(s)."
The agency also questioned Intas' air flow conditions because there have been no smoke studies performed at the site. The FDA added that it might conduct more inspections and can withhold approval of new drug applications until the problems are addressed.
In November 2022, the FDA stalled imports of some medications made at the facility, and drug supply experts have pointed to this action as the reason for monthslong shortages of multiple cancer therapies, including mainstay treatments cisplatin and carboplatin. Accord Healthcare, the parent company of Intas, recently resumed making cisplatin.
The FDA asked Intas to report any potential drug supply disruptions as it works to improve its quality processes.