Jeremy B. Zucker
Washington, D.C. +1 202 261 3322
As FDA has stepped up inspection of API and finished drug manufacturing facilities outside the United States, its inspectors are uncovering more reasons for drug company sponsors to do what they should be doing anyway: assessing and monitoring their suppliers’ and business partners operations, quality systems, employee training, and overall business practices. Caution is required with all business partners, but can be much more complicated when these partners are thousands of miles away and do business in another language and culture.
Read the full article quoting Jeremy Zucker and Kareena Teh: "Ensuring Supply Chain Safety."
Read the accompanying sidebar article quoting Lewis Ho: "More inspections, and regulator collaboration, offshore."