Home » Swiss Regulator Writes Up Indian Firm for Multiple Violations
Swiss Regulator Writes Up Indian Firm for Multiple Violations
Switzerland’s drug agency Swissmedic rapped an Indian drugmaker for significant CGMP violations at a facility near Mumbai.
The Swiss investigators discovered five serious violations and numerous others at the Acharya Chemicals facility — including failing to control the risk of cross-contamination and not properly preparing before introducing a new chemical entity into the synthesis area.
Acharya failed to qualify or properly monitor its raw material storage area, posing a risk for the starting material metronidazole, Swissmedic said, in a report to the EU’s EudraGMDP inspection database.
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