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More GMP Warnings, Import Alerts For OTC Firms As US FDA Capped List Of Uninspected Facilities

Executive Summary

Most of the foreign OTC drug firms targeted in latest warnings FDA published, including the GUM oral care brand manufacturer, were placed on import alert due to GMP violations. Each was inspected by FDA during June, July or May 2019, when the agency was wrapping up an initiative to inspect all previously uninspected drug manufacturers.

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