US FDA Suspends All Domestic GMP Surveillance Inspections

By Joanne S. Eglovitch, Senior Editor Manufacturing, “The Pink Sheet”
joanne.eglovitch@informa.com

FDA Sign

Agency responds to COVID-19 pandemic’s US arrival by suspending domestic surveillance inspections and non-critical for-cause and preapproval inspections.

The US Food and Drug Administration announced a suspension of all domestic good manufacturing practice surveillance and non-critical for-cause and preapproval inspections for the duration of the COVID-19 public health crisis as part of decision to require all eligible employees to telework. The aim is to wind down all inspections by 3 April.

Exceptions will be made for inspections of facilities manufacturing medically necessary products, such as products to treat and prevent COVID-19 and breakthrough products such as new cancer treatments.

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