FDA wants to increase Number of foreign Inspections

Recommendation
27/28 May 2025
Supervision of the Pharmaceutical Quality System: Challenges and Opportunities
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
Related GMP News
30.04.2025QP Declaration: New Q&As published
19.03.2025Root Cause Analysis: Again, problems discovered in GMP-Inspections
19.03.2025ICMRA publishes Hybrid Inspection Pilot Summary Report
19.03.2025From Burkholderia to Ethylene Glycol - a List of Deficiencies at a Manufacturer of OTC Products
19.03.2025Warning Letter - Deficiencies in the Control of Raw and Starting Materials
19.03.2025Inadequate Microbiological Testing of Nonsterile Products - FDA Warning Letter