GAO critical of FDA’s overseas inspections

By Nick Taylor

- Last updated on GMT

Related tags: Fda, Government accountability office

A report has been published detailing the US Food and Drug Administration’s (FDA) failings in its inspection of overseas manufacturing facilities.

The US Government Accountability Office (GAO) has released the report, which accuses the FDA of failing to keep accurate data about overseas drug facilities and not following up warning letters with inspections.

In the fiscal years 2002 to 2007 the FDA issued 15 warning letters to overseas manufacturers citing serious deficiencies but failed to adequately follow these up, according to the report.

The GAO found that after issuing the letters the FDA re-inspected four of the facilities but not until two to five years after it had initially discovered the faults.

To remedy this situation the GAO has made five recommendations to the FDA, one of which suggests the agency should perform the same number of inspections overseas as it does in the US.

Logistically this poses a considerable challenge, as at the current rate of overseas inspections it would take more than 13 years to visit all of them. In contrast, facilities in the US are inspected every 2.7 years on average.

However, the exact time it would take to investigate the overseas facilities cannot be said with any great accuracy as the GAO found that the FDA does not now exactly how many sites ship drugs to the US.

The FDA uses two databases to monitor foreign facilities. One lists establishments registered to market drugs in the US and the other is a database of facilities that have shipped drugs to the US, which contain around 3,000 and 6,800 sites respectively.

In addition the GAO does not believe these numbers cannot be viewed as a definitive as it found that the FDA does not routinely verify that a registered establishment manufactures drugs for the US market.

FDA under the spotlight

Overseas inspections have become an increasingly charged topic over the past 12 months, with the heparin scandal causing the US Congress to pay more attention to the topic.

Consequently, Congress has launched an investigation into the FDA’s handling of the alleged problems at two of Ranbaxy’s manufacturing facilities in India. Another strand of this has been Congress’ questioning of the FDA’s interactions with Actavis.

With the spotlight of the media and government upon it the FDA has attempted to rectify some of its perceived shortcomings and as part of this will be stationing inspectors in India and China.

The report acknowledges this but believes that: "given the growth in foreign drug manufacturing for the US market, and the large gaps in FDA's foreign drug inspection program, significant challenges remain​."

A complete copy of the report is available here​.

Related topics: Regulatory & Safety, QA/QC

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