More GMP Warnings, Import Alerts For OTC Firms As US FDA Capped List Of Uninspected Facilities
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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US FDA warns that Health Pharma USA was shipping product before its quality unit could review and test it.
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.
Cross Brands violated GMP including verifying the identity of ingredients and made acne- and eczema-treatment label claims for products not covered under the OTC drug monograph, says FDA in a warning letter.