FDA Inspection Bound to Increase - Did You Know?

Did You Know?

According to a recent article1, the FDA is taking inspections in countries outside the U.S. more seriously than ever before. So seriously in fact that overseas inspections are likely to rise by as much as 50 percent.

This new focus on inspections abroad has been stimulated by recent quality mishaps and outright disasters in China in conjunction with public fear that suppliers in India, Mexico and anywhere else outside of the United States will follow suit because they aren't held to the same standards as their U.S. counterparts. To offset the possibility of these mishaps and the generation of public fears, the FDA is setting its sights high to regain the public trust and show that the FDA has the flexibility necessary for the management of a worldwide compliance enforcement operation.

What They Will Look For

During inspections conducted abroad, the FDA will be likely to focus on basic issues such as sterility levels but other concerns can be raised at any time and the entire supply chain will have a higher chance of being audited as as opposed to auditing the "tail-end" supplier only.

To learn more about the FDA's possible increase in overseas inspections please read the following: http://www.clinica.co.uk/policyregulation/regulation/FDA-foreign-inspections-may-go-up-by-50-this-year-187527?autnID=/contentstore/clinica/codex/c5cdaef6-100b-11df-b0f6-03cca73eb886.xml


1. FDA foreign inspections may go up by 50% this year (http://www.clinica.co.uk/policyregulation/regulation/FDA-foreign-inspections-may-go-up-by-50-this-year-187527?autnID=/contentstore/clinica/codex/c5cdaef6-100b-11df-b0f6-03cca73eb886.xml)