FDA, MHRA See Rise in Overseas Inspections

The FDA and MHRA have upped their inspections of foreign facilities in the past four years, according to agency reports.

In the last fiscal year, the FDA inspected a total of 78 overseas facilities, compared to just 69 the prior year. The MHRA conducted nearly the same number of assessments in 2015, inspecting 79 foreign facilities — up from the 42 inspections reported in the agency’s last review of GMP deficiencies.

The uptick in FDA inspections comes after Congress had asked the agency to evaluate its oversight of foreign facilities in 2015 to ensure its approach to domestic and foreign inspections is appropriate. The House Energy and Commerce Committee had expressed concerns about the FDA unfairly targeting U.S. facilities and requested that the GAO also review the FDA’s procedures for developing and implementing risk-based inspections.

The FDA did not detail its inspection findings, but the MHRA noted hundreds of major deficiencies related to quality systems. The handling of complaints and recalls came in as the second most common deficiency. Documentation, quality control and computer system issues were also among the top inspection concerns.

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