Becker's Healthcare June 20, 2023
FDA investigators discovered more quality issues at an Intas Pharmaceuticals factory in Ahmedabad, India, which halted some production after a November inspection found a truck full of shredded documents, Bloomberg reported June 15.
In May, the FDA inspected the facility and investigators said they could not ensure the “safety, efficacy, purity and overall quality of drug products manufactured” at the site, according to a 30-page report obtained by Bloomberg.
Some drug supply experts have pointed to the site’s shutdown in November as a cause of the shortages of cisplatin and carboplatin, two cancer drugs that have seen low supply for months. Intas produced about 20 percent of the nation’s supply of carboplatin, according to The Wall Street Journal....
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