New Jersey OTC Firm Lacked GMP Basics, FDA Warning Letter Says
US FDA warns that Health Pharma USA was shipping product before its quality unit could review and test it.
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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.
Later this year, FDA expects to complete initial inspections of every facility that manufactures drugs for the US market. As the agency visits under-the-radar facilities recently targeted as part of an effort to leave no site uninspected, it is finding that they are more likely to have serious drug GMP issues.
Site-based metrics praised; lot acceptance rates, invalidated OOS rates discouraged. Agency official admits some proposed metrics were “not the best.”