FDA’s Top Ten Drug GMP Citations

At the FDA/Xavier University PharmaLink conference at Xavier University in Cincinnati, Ohio, in March 2017, FDA’s Robert Tollefsen and Dell Moller presented the top ten drug GMP inspection citations for FY 2016. As summarized by Elanco’s Brent Conatser these citations relate principally to small drugs. However, the same considerations apply to the manufacturing of biologics and Somatek has encountered one or more of these issues at client sites and also at CROs. Somatek will work diligently with client’s personnel and contractors to address problems before they rise to the attention of the agency. Please read to full write-up by Brent Conatser here https://www.xavierhealth.org/news3/2017/12/4