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

 
• By Malcolm Spicer

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.

Another week, another batch of US Food and Drug Administration warning letters to foreign firms making OTC drugs that were inspected in mid-2019 as the agency checked some of the final facilities off its list of the uninspected.

And for most of the foreign OTC drug firms targeted in the latest warnings the FDA published, the agency's findings of good manufacturing practices violations

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