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Page 2 of 42 December 2019 eBook BioPharm International 3 Warning Letters Signal Steps to Compliance Warning letters tell the tale of missteps by drug companies and offer a path to compliance for quality teams that monitor these enforcement actions. B arring a flurry of approvals in the last few weeks of 2019, the number of new drugs approved by FDA in 2019 will fall signifi- cantly below the record-setting 59 approved in 2018. As of Dec. 10, 2019, FDA had approved 41 new molecular entities and new therapeu- tic biological products in 2019, similar to the number of approvals in 2017 and 2015 (1). While approval numbers were down, the number of warning letters issued for violations of good man- ufacturing practices and distribution of adulterated or unapproved drugs increased from 121 in 2018 to 137 for 2019 (through December 10). On a positive note, the number of warning letters are down from 178 let- ters in 2016; however, nearly 70% of the letters went to US-based firms in 2019, up from less than 50% in 2018 (2). Warning letters not only put the offending drug company on notice; these enforcement documents serve as an early alert system to drug manufacturers by identifying commonly cited violations. This informa- tion should prompt drug companies to examine their own operations—and those of contract manufacturers and suppliers—for potential problems. In many warning letters, FDA concludes that a com- pany's quality systems are inadequate. While the spe- cific infractions vary from letter to letter, common infractions include the following: VEGEFOX.COM - STOCK.ADOBE.COM RITA PETERS Regulatory Sourcebook Enforcement Update

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