The FDA’s recent and ongoing focus on over-the-counter (OTC) drugs and other health products intensified with the agency issuing warning letters to four companies with very similar citations.

The agency referenced these findings to point out its industry-wide concern for violations it said puts consumers at significant risk. These include insufficient quality controls for potentially hazardous products and skipped safety tests that have led to potentially harmful contamination in multiple products.

While these latest crackdowns target producers of homeopathic products specifically, (an area which began attracting greater attention from regulators back in 2015) the broader OTC manufacturing field has come under greater oversight, as evident by recent inspection and enforcement trends.

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