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Quality Concerns to Resurface as FDA Resumes Foreign Inspections, Bloomberg Law

Thursday, March 17, 2022

The Food and Drug Administration (FDA) restarted its domestic surveillance inspections in February, with plans to begin conducting foreign prioritized inspections in April. Among the challenges that the FDA faces when conducting overseas inspections, partner Dennis Gucciardo noted that keeping records can be difficult to understand due to language barriers and being too reliant on translators. “When you translate records, it is a story, and it depends on how the translators view it. Some language colloquialisms are not equivalent and, of course, it can lead to confusion.”

Lessons learned from the pandemic highlight a need for the FDA to have more flexibility to conduct foreign facility reviews in the event of future public health emergencies. “The best way to conduct reviews is to see a company’s everyday practices in action,” commented partner Jacqueline Berman. “The point of an inspection is to see how the facility is operating under real-world conditions.”

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