FDA wants to increase Number of foreign Inspections

Recommendation

5/6 October 2023
Heidelberg, Germany

Quality Culture
People Empowerment in GMP

In its proposed fiscal 2015 budget, the U.S. Food and Drug Administration FDA details the plans for their inspections in the new fiscal year. The agency would like to perform approx. 20 percent more foreign GMP inspections, from 827 in the year 2013 up to 999 in 2014 and 2015. The companies will be inspected based on a risk-based inspection model taking into account for example Class I recalls, adverse events and the compliance history.

FDA prioritises inspections at high-risk domestic and foreign companies. As a result, "in FY 2013 FDA has met or exceeded inspection targets for human drugs facilities". In the fiscal year 2013, 443 domestic and 365 foreign high-risk drug establishments have been inspected, 43 GMP-based Warning Letters were issued.

The total number of inspections in the U.S. will stay almost consistent, with a decrease of Drug Processing (GMP) Program Inspections from 967 to 591. The number of Pre-approval Inspections (PAI) and Adverse Drug Events Project Inspections will increase.

Source: Department of Health and Human Services Fiscal Year 2015 Justification of Estimates for Appropriations Committees