FDA Resumes Foreign Inspections Amid Quality Concerns

FDA Resumes Foreign Inspections Amid Quality Concerns

March 28th, 2022 // 1:32 pm @

FDA resumed domestic drug and device inspections in February 2022 that sometimes result in a 483 or FDA warning letter, and is about to resume foreign inspections, as well.

As the agency confronts a two-year cgmp inspection backlog after its COVID-19 pause, lawyers say FDA should use this as an opportunity to deal with frequent complaints about its FDA foreign inspection methods. They say that if they increase FDA staff overseas, use more unannounced inspections, and hire more translators, the quality of the inspections will improve.

A common complaint with FDA’s foreign inspections is they weren’t meaningful enough, meaning the inspections weren’t rigorous, which led to serious quality issues in some overseas drug facilities.

When the pandemic began, FDA put a focus on on-site evaluations that it said was ‘mission-critical inspectional work.’ FDA started to go back to standard numbers of domestic drug and device inspections in July 2021. By the end of 2021, it had conducted at least 1100 inspections.

But foreign inspections were mostly delayed with the FDA doing only 124 in 23 countries from April-September 2021.

A February GAO report stated FDA had gotten better with oversight on foreign drug manufacturing over the last two decades. But there were problems with workforce retention and keeping a regular timeline for FDA audits. This is becoming a bigger problem as more manufacturers move their plants outside the US.

Some lawyers that offer consulting services to foreign clients say FDA should offer more remote surveillance inspections and get help from third-party inspectors to do on-site audits. Others maintain that only having onsite inspections by FDA can meet the high standard for drug and device product approvals.

FDA noted this month that the agency is working on an unannounced foreign inspection system as the agency boosts recruitment and retention for inspectors based abroad.

Another problem with FDA foreign inspections for years has been worker shortages and translation problems. The GAO noted in its recent report that foreign inspections are challenging because the auditor must work on their own in a foreign facility on tight timelines. Most foreign inspectors are from the US.

The GAO notes that FDA’s foreign inspection team has had difficulty staying staffed because it is hard to find inspectors who can make the regular trips overseas. Foreign inspection team members usually do six three-week overseas trips annually. They have to take flights of 12 to 16 hours to China, India, and other far-flung places to do onsite inspections.

FDA officials note that foreign inspection work is very isolating and the auditors have to deal with a foreign language and culture. And FDA inspectors also must be experts in the subject matter.

FDA also needs translators to go over reports provided by drug and device companies overseas. FDA usually relies on translation services from the plant being inspected or staff in the nearest FDA office. Getting better translators and more of them is a major area of improvement the FDA will target this year.

For example, when records are translated, there is a long story involved and how it is told depends on who is translating it. Some colloquialisms in different languages don’t translate accurately to others and there can be confusion.

FDA is going to launch a pilot soon that will improve connections with third-party translators, including with an effort with the State Department.

Subscribe Now

Featured Partner