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In a recent episode of our podcast, The Life Science Rundown, The FDA Group's Nick Capman spoke with George Toscano, President & CEO of Toscano Consulting Group, to explore recent FDA enforcement trends and the nuances of the FDA inspection process, especially in light of the COVID-19 pandemic's impact on the industry.
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Mr. Toscano is a highly experienced consultant with expertise in international compliance, data integrity, and quality systems. He has an excellent track record of managing FDA enforcement actions and has extensive knowledge in laboratory and manufacturing investigations, CAPA, change control, and stability programs.
In addition, he has also led analytical R&D labs and overseen product development and regulatory submissions. Recently, he played a vital role in spearheading a multi-year expansion and remediation for a biologics manufacturer under a consent decree.
A few key points from the discussion:
Recent FDA Enforcement Trends:
George discusses the influx of new entrants into the pharmaceutical space during COVID-19, particularly with hand sanitizers.
Issues with companies not accustomed to GMP, leading to deficiencies.
FDA's focus on testing for diethylene glycol and ethylene glycol in components.
The quality unit's lack of authority in some companies, especially OTC manufacturers, leading to inadequate testing and compliance issues.
An increase in focus on ophthalmic products due to contamination issues.
FDA Inspection Process:
There was a significant reduction in on-site inspections during COVID-19, with a shift to remote evaluations and document requests.
The FDA is ramping up on-site inspections again but still utilizes remote tools.
Warning letters are being issued based on remote document reviews.
FDA Inspection Trends and Predictions:
George notes that drugs have the worst compliance scorecard compared to biologics and devices.
He predicts that ophthalmic products might be a focus area for the FDA.
Data integrity issues have been a significant focus, especially in India.
The FDA's "waves" of focus, which last 18-24 months, are discussed, with a recent wave on OTC manufacturers before COVID-19.
Persistent FDA Observations:
Failure to conduct adequate investigations is a perennial issue cited by the FDA.
Lack of written procedures or failure to follow procedures is another common finding.
Toscano discusses the cycle of manufacturing batches, deviations, and the complexity of processes, especially in biologics.
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Recent FDA Enforcement Trends with George Toscano