FDA’s Record-Number GMP Warnings In FY 2019 Included First Of A Kind
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.
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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.
2019 saw Indian companies advance innovation efforts and build and expand their specialty portfolios and biosimilars businesses. But manufacturing compliance issues weighed down several firms while on another front charges against the Singh brothers of Ranbaxy escalated.
Examples of unfinished business from 2019 include no legislation passed to reform OTC monograph program; FDA putting off until May the planned publication of an NPRM to allow firms to submit OTC NDAs with extra-label information to help guide consumers' self-selection; and no OTC naloxone for opioid overdose approved even after FDA's unprecedented step of developing model DFLs sponsors could use for their own label comprehension studies.