FDA Inspections in the Wake of the COVID-19 Pandemic

How does FDA compare to other global regulatory agencies when it comes to virtual inspections? What alternatives to in-person inspections have pharmaceutical companies experienced? And how do FDA investigators adhere to state-level COVID-19 restrictions when onsite inspections do occur?

Last December, talks at the FDLI Enforcement, Litigation, and Compliance Conference addressed these questions and more. Redica Systems Senior GMP Quality Expert Jerry Chapman covered these talks in three Conference Spotlight articles.

FDA Inspections During Covid Articles:

• FDA Chooses Not to Perform Virtual Inspections in Contrast with Non-U.S. Agencies Find out what one major pharmaceutical company experienced as far as FDA inspections in 2020. Plus, a look at how the agency conducted document requests in lieu of an inspection.
• Desk Inspections, Missed Action Dates Take Place of FDA In-Person Site Visits A consultant discussed his clients’ experiences with inspection alternatives. He also offered advice for manufacturers on how to work with FDA in the current inspection environment.
• Onsite Pharma FDA Inspections During COVID-19 Respect State Restrictions In the event of an onsite inspection, learn what should be considered when it comes to adhering to state-level restrictions. Also, pharmaceutical manufacturers can learn from medical device manufacturers when it comes to remote inspections.

[Related: For more on virtual inspections from Jerry Chapman, download his 2020 report that includes a look at an innovative technology that drew praise from an EMA inspector.]