Chinese OTC Patch Manufacturer Feels Pain Of US FDA Import Alert, Warning
FDA places Kangdi Medical Devices on import alert and warns it on GMP violations initially noted in 2016. FDA also notes in warning that the Chinese company’s two pain-relief patches are noncompliant with the external analgesics TFM.
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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.
FDA says Wild Child, which provides products as a contract manufacturer and for private label sales, violated drug GMPs for products including sun care, lice treatment and acne lotion and attempted to avoid US testing standards by relying on Australian mandates.
Total GMP warnings in FY19 was 98, more than half to US firms. Warning to Dollar Tree “should serve as a reminder that although distributors may not be subject to CGMP requirement themselves, they are responsible for ensuring the drugs they distribute into interstate commerce are not adulterated,” says CDER compliance chief Donald Ashley.