A year after the FDA found shredded quality documents at an Intas Pharmaceuticals drug manufacturing facility in India, Intas' parent company Accord Healthcare resumed making cisplatin, which has been in dire shortage for months.
In November 2022, the FDA inspected Intas' factory in Ahmedabad, India, and found acid poured on drug quality control documents and torn reports stuffed in bags, which were placed under a stairwell, in a scrap room and in a truck on the facility's campus. In response, the agency halted some production and imports.
By early 2023, cisplatin, carboplatin and a few other popular cancer drugs were in short supply. The shortages have hindered care at cancer centers and hospitals across the country as clinicians rationed supply, but the shortages began easing in the fall.
Accord has resumed manufacturing batches of two cisplatin solutions, according to a Nov. 13 update in the FDA's drug shortage database.