The following is from Becker’s Hospital Review.
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.
The latest report could spur worsened drug shortages, Bloomberg reported, because the May visit found employees altering recorded data that did not meet U.S. standards for particles, such as black specks, fiber and glass, found in injectable drugs. The FDA also recorded evidence of Intas employees disregarding three years’ worth of more than 1,000 “spore-forming organisms.”
On June 1, the FDA instituted an import ban on all but 25 of Intas’ drugs made at its three India-based facilities, according to agency documents.
The products excluded from the import ban include multiple cancer drugs in shortage, including cisplatin, carboplatin, fluorouracil and docetaxel.
The drugmaker also has not verified its quality test procedures for more than 100 of its drugs. Intas did not respond to Bloomberg‘s requests for comment.
Link to article here.
