Volume 94 Issue 2 | p. 6 | News of The Week
Issue Date: January 11, 2016 | Web Date: January 7, 2016

FDA Issued Warning Letter to Cadila Healthcare

Company becomes latest Indian firm to fail to comply with U.S. standards
Department: Business
Keywords: India, compliance, pharmaceuticals, FDA, data integrity

Cadila Healthcare, a major Indian generic drug company, has become the latest pharmaceutical manufacturer with a plant in India to be issued a U.S. FDA warning letter for failing to meet the regulatory standards of the U.S.

Warning letters are issued to firms that, during an inspection by FDA officials, are found to breach pharmaceutical manufacturing regulations. Recipients of the letters are often, but not always, banned in the U.S. from selling finished drugs and . . .

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