When FDA perceives a corporate pattern of quality failures, it will use warning letters to connect the dots and press for a company-wide response to the failures, as it did in an Aug. 9 warning letter to Apotex Research Private Ltd.
Even though warning letters stem from inspections of individual sites conducted to appraise compliance of those sites’ quality units with drug GMP requirements, the Apotex warning letter underscores the broader view that FDA takes in assuring compliance, consistent with International Council on
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