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Pharmaceuticals / Inspections and Audits

FDA Warns Indian Drugmaker for CGMP Violations

March 4, 2019

Vipor Chemicals drew a warning letter from the FDA for CGMP violations observed during an inspection last year at its facility in Vadodara, Gujarat — including the use of an API supplied by a manufacturer on an FDA import alert.

The Feb. 21-24, 2018 inspection revealed that the facility’s quality unit failed to include the name and address of an API’s original manufacturer on certificates of analysis given to customers. The ingredient’s manufacturer — another Indian drugmaker — was placed on import alert by the FDA in October 2017 after it refused to allow an FDA inspection.

“You should be aware of your suppliers’ regulatory status prior to purchasing and distributing API from them,” the agency said.

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