Report: Challenges with FDA Inspections

Recommendation

5/6 October 2023
Heidelberg, Germany

Quality Culture
People Empowerment in GMP

The US Government Accountability Office GAO has published a statement which indicates persistent challenges with FDA foreign inspections. GAO has been having concerns about FDA's ability to oversee the global supply chain of drugs. Already in 2008 GAO recommended to increase the number of foreign inspections. After that, FDA was conducting more of these foreign inspections.

This new statement is now based on ongoing work and provides information on:

• the number of foreign inspections FDA has conducted,
• inspection staffing levels,
• challenges unique to foreign inspections.

Here are some of the results; details can be found in the 32 page document.

Although the number of foreign drug manufacturing inspections had increased from 2012 through to 2016, the numbers of both foreign and domestic inspections have been decreasing ever since. According to FDA, one reason might be "vacancies among investigators". "FDA had 190 investigators in the United States who conduct the majority of foreign inspections, but an additional 58 positions were vacant." However, vacancies in FDA's foreign offices were also noticed.

A challenge in conducting foreign inspections is the fact that these are announced up to 12 weeks before the inspection date. This might "give manufacturers the opportunity to fix problems".

Another challenge is the necessary use of translators. This sometimes raises concerns about the accuracy of information.

Finally it was concluded that "foreign manufacturing establishments continue to be a critical source of drugs for millions of Americans, and FDA inspections are a key tool to ensure the quality of these drugs". GAO recognises FDA's efforts to adapt to the changes coming with globalisation. However, it criticises that FDA "continues to be faced with many of the same challenges in the oversight of foreign establishments" that were identified back in 2008.