STAT+: FDA will allow troubled chemotherapy maker to resume distribution of cancer drugs in short supply
"It’s nerve wracking — his company runs a factory that made a significant portion of chemotherapy drugs, and had numerous problems."
After finding a “cascade of failures” at a manufacturing plant run by a key chemotherapy supplier, the Food and Drug Administration will not allow the company to resume distribution in the U.S. beyond some cancer medicines that are in short supply.
The agency issued the import alert last week to Intas Pharmaceuticals, which is based in India, after its inspectors found a litany of quality-control problems that were detailed in a 36-page inspection report in December. The inspectors found issues with data integrity and procedures designed to prevent microbiological contamination, among other problems.
Notably, the FDA inspectors found a truck that was waiting for clearance to leave the facility and was carrying plastic bags that contained shredded documents. Intas employees subsequently acknowledged the materials were generated on the same days last November that the FDA team was visiting the plant in Gujarat, India, according to the inspection report.
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