www.fdanews.com/articles/123411-fda-8217-s-enforcement-crackdown-to-increase-inspections-delays
FDA’s Enforcement Crackdown to Increase Inspections, Delays
January 5, 2010
Drugmakers and importers may expect
delays in 2010 as the FDA trains more than 1,000 staff hired last year to conduct inspections and import screenings. New employees probably will be trained
at the borders because that’s where the highest volume of regulated commodities can be found, Benjamin England,
founder of FDA Imports, said. The agency often stations new employees with veterans at the U.S. borders with Mexico and Canada to receive training in FDA
law, regulations and requirements, he said. The staff increase may intensify the scrutiny of products, which in turn may cause delays.
Drug GMP Report
Drug GMP Report