The QMN Weekly Bulletin

Taiwan Three Mast Fails to Meet ‘Fundamental cGMPs,’ Warning States

Jan. 11, 2013

Taiwan Three Mast Pharmaceutical is holding an FDA warning letter after falling short of “fundamental cGMPs,” the FDA says.

For example, the company did not test raw materials and finished drug products, used unvalidated manufacturing processes and lacked basic cGMP training at its facility, according to the Dec. 17 warning letter posted recently online.

The company did not test incoming lots of menthol and methyl salicylate APIs prior to their use in production, instead relying solely on suppliers’ certificates of analysis. Further, it had not established assay methods to determine the strength of these ingredients in its finished drug products. Taiwan Three Mast only identified these ingredients by thin layer chromatography, the letter notes.

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