FDA’s Enforcement Crackdown to Increase Inspections, Delays

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. Additionally, minor technical violations may be written up because new employees will be on the lookout for any violation at first, he said.
Drug GMP Report