Months after the FDA reported multiple violations at an Intas Pharmaceuticals plant in India and blocked imports, the agency shared more details Aug. 1, including a report of an analyst pouring acid in a trash can filled with drug quality documents.
Intas has been restrained from importing multiple solutions. The company manufactures carboplatin and cisplatin, two therapies used to treat multiple cancers that have been in severe shortage for months after the FDA halted some of Intas' imports.
Past reports on the facility found employees altering recorded data that did not meet U.S. standards for injectable drugs, such as particles of black specks, fiber and glass. The FDA also recorded evidence of Intas employees disregarding three years' worth of more than 1,000 "spore-forming organisms."
The FDA posted a warning letter to its site Dec. 2 that detailed investigators finding a truck full of shredded documents. In the Aug. 1 warning letter, more information was revealed.
Here are seven things to know:
1. Investigators found plastic bags filled with torn quality documents stuffed under a stairwell, in a scrap room and in a truck on the facility's campus.
The destroyed documents included "engineering checklists associated with the Environmental Monitoring System, torn Karl Fischer analytical test reports, auto titration curves and analytical balance weight slips for finished drug products," the warning letter said. The KF reports stuffed in the trash bag could have been saved electronically, but they were not, according to the FDA.
2. An analyst poured acid in a trash bin containing drug quality documents, and an employee said the same analyst has destroyed documents on KF titration curves and balance.
3. A worker tossed test results for a depression drug, amitriptyline hydrochloride tablets, and time stamps did not match up. "You did not adequately address the major failure of laboratory operations," the agency said, "and quality assurance management to conduct proper oversight over documentation and prevent data integrity lapses."
4. Intas' electronic batch records can be manually changed, and in one instance, an FDA inspector saw a production employee alter a time for an operation. In response, the company established procedures but failed to explain the management issues and its computer data integrity, according to the FDA.
5. Hundreds of chromatographic sequences were "aborted," and colony-forming units and a carboplatin injection batch were miscounted, the FDA said. The quality assurance department also did not "ensure raw materials used in the manufacture of drug products were appropriately tested."
6. The findings from the inspection, which was performed from Nov. 22 to Dec. 2, paralleled violations found in May 2019. "Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate," the warning letter said.
7. The FDA outlined numerous requests for more information and plans for future quality assurance, and if these are not met, the agency said it could continue to ban Intas imports.