News about GMP/cGMP

21.01.2022

FDA: Hold on Inspections

FDA: Hold on Inspections

The US FDA announces that the spread of the Omicron variant will lead to further delays in resuming inspection activities. Originally, this step was planned for February 2022. The date is now being pushed further back. With the current developments of the Covid 19 pandemic, no new resumption date has been communicated.  


What is planned?

  • FDA will conduct "mission critical" inspections overseas but will also reassess at short notice depending on urgency and travel conditions.
  • The agency is also postponing the scheduling of priority surveillance inspections abroad, planned to begin in February 2022.
  • FDA will continue to conduct mission-critical inspections domestically.
  • Importantly, the agency will seek to maintain remote inspections to monitor foreign manufacturers as best as possible. To do so, the FDA will continue to rely on alternative tools to keep an oversight.

Source:

FDA: January 4, Roundup


 

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