Covid-19: FDA Postpones Domestic and Foreign Inspections

In response to the COVID-19 outbreak, the U.S. Food and Drug Administration FDA has decided to postpone most foreign inspections until the end of April. This decision is already effective. However, foreign inspections (outside the U.S.) which are deemed critical will be considered on a case-by-case basis and might still be conducted.

FDA is aware that this might have an impact on other FDA responsibilities and activities, including product application reviews and product safety. Therefore, temporary tools will be employed to ensure the safety of products. Together with U.S. Customs and Border Protection, the aim is to prevent unsafe products from entering the US market. This can be supported by:

  • physical examinations and/or product sampling at the border,
  • reviewing a firm's previous compliance history,
  • using information sharing from foreign governments as part of mutual recognition and confidentiality agreements,
  • requesting records "in advance of or in lieu of" on-site drug inspections,
  • application of the risk-based import screening tool (PREDICT).

Meanwhile, FDA announced that all domestic routine surveillance facility inspections are temporarily postponed as well. Routine surveillance facility inspections are facility inspections that FDA conducts routinely every few years based on a risk analysis. However necessary domestic for-cause inspection will be evaluated and "will proceed if mission-critical".

FDA continues to monitor this outbreak and the impact to its operations and stands "ready to resume foreign inspections as soon as feasible".

Source: FDA Press Announcement

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