FDA and MHRA Break Down Foreign Inspection Data

Posted 11 January 2017 By Zachary Brennan

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Both the US Food and Drug Administration (FDA) and the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) are slowly ramping up their inspections of foreign manufacturers, according to the latest statistics.

On FDA’s side, investigators conduct on-site inspections of regulated foreign establishments to proactively ensure the safety and efficacy of products manufactured abroad and sold in the US.

In FY 2016, FDA conducted 78 foreign inspections of human drugs and nine for medical devices, which was slightly more than 2015’s 69 foreign inspections of human drugs and 10 device inspections (not to be confused with the 620 foreign quality system inspections from 2015 or the more than 2,000 Class II and Class III device inspections). The only other data FDA offers is from

July through September of 2014, when the agency conducted 18 foreign inspections for human drugs and four for devices.

By comparison, MHRA on Wednesday released its figures for GMP inspections conducted in 2015, noting a total of 79 overseas inspections and 224 UK inspections. The report also broke down the most frequently cited deficiencies:

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In addition, MHRA offered a long list of deficiency examples, including: out of date training of aseptic area operators and annual competency checks for all relevant staff, no formal procedure to ensure that all updates to EU good manufacturing practices (GMP) were captured, reviewed and implemented, as well as no root causes identified and subsequently no actions taken to prevent any recurrence.

The release of the statistics comes as the US and EU are still trying to forge a way to mutually recognize good manufacturing practice (GMP) inspections.

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Categories: Biologics and biotechnology, Drugs, Medical Devices, Manufacturing, Regulatory strategy, Regulatory intelligence, News, US, Europe, FDA, MHRA

Tags: foreign drug inspections, foreign device inspections

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