FDA inspection at India pharma at center of the cisplatin shortage cites multiple quality issues
An FDA inspection of the Intas Pharmaceuticals manufacturing facility in India that produces the cancer drug cisplatin, now in short supply, found instances of manipulated documents and cleaning violations.
The 483 inspection report was obtained by Endpoints News via a FOIA request. It revealed a range of issues at the plant in Ahmedabad, India, including visual inspection records that had been altered to lessen the risk of a batch investigation and complaints of odors and smells that were never checked out.
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