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FDA Warning Letter Cites Canadian Drugmaker for Vendor Qualification Lapses

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The FDA has hit International Laboratories Canada with a warning letter for GMP violations related to supplier qualification and the company’s quality control unit. A February inspection revealed the custom OTC products maker did not establish the reliability of its suppliers through validation test results at appropriate intervals. The company relies on suppliers’ certificates of analysis without conducting adequate vendor qualification or specific identity tests of incoming components, the letter states.
Drug Industry Daily