FDA’s New Criminal Investigations Chief Wants Global Reach
This article was originally published in The Gray Sheet
Recently appointed Office of Criminal Investigations Director George Karavetsos talks about expanding the global presence of his office to protect product safety in the U.S. in an interview.
You may also be interested in...
President Obama’s FY 2016 blueprint includes cuts to ‘low-priority’ enforcement, surveillance and other activities in FDA human drugs and biologics programs, but still increases those operations overall.
Most of the 150 warning letters issued by FDA last year were sent to foreign manufacturers, a “Silver Sheet” analysis shows. That letters to overseas companies have outpaced those to domestic ones is a surprise given that the agency performs nearly four times as many inspections of U.S.-based facilities each year. But the foreign warning letter increase in 2013 might actually be a sign that FDA’s enhanced focus on overseas compliance in recent years has begun paying dividends. In related warning letter trends, CAPA has supplanted complaint handling as the No. 1 deficiency area cited in letters. Further, 56 close-out letters were sent to firms in 2013, down slightly from 2013.
OCI Director John Roth set to depart upon his confirmation to Homeland Security Department post.