Warnings Up As US FDA Trims List Of Uninspected OTC Drug Manufacturers
Executive Summary
Hundreds of foreign firms making OTC drugs marketed in US had not been inspected for GMPs compliance before FDA Safety and Innovation Act pointed agency toward crossing those facilities off its list. Of the foreign OTC facilities inspected between June 2016 and Jan. 9, 2018, 25% received "official action indicated" inspection results, driving warning letters and import alerts.
You may also be interested in...
US FDA Crossing Off More Foreign OTC Firms On Globalization Checklist
FDA issued 39 warning letters to OTC drug facilities, most of them outside the US, in 2017, a number significantly boosted by an initiative to inspect a total of 1,000 foreign drug manufacturers from January 2017 through September 2019 , says CDER compliance director Donald Ashley. Many GMP violations behind FDA's warning letters concerned “rudimentary" requirements.
FDASIA Study Mandates Focus On Performance, But Could Slow Reviews
Advocates for the agency worry that while each of the performance assessments seems reasonable individually, together the reports could burden staff to the point of pulling some from application reviews or other tasks to help complete them.
Abbott's ‘Bedrock Of Good Health’ Nutritionals Business Faces Mounting Infant Formula Litigation
Nutritional product business had 5.1% Q1 sales growth and is like Abbott’s other segments, “super well-aligned to the global demographics and trends in health care,” says CEO Ford. But as it defends complaints of damages from powder formulas made at facility found with unsafe levels of bacterial contaminants, Abbott’s also targeted in litigation alleging failure to warn about risk of infants born prematurely developing necrotizing enterocolitis if fed cow’s milk-based formula.