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FDA has stopped Inspections – Elexes
Elexes Medical Consulting

FDA appreciates product firms for non-violation of its rules and regulations and continues to be in contact with firms during this difficult time. Considering that the overall domestic compliance violations were only 5% the last fiscal year and keeping in mind the health and wellbeing of its staff, contractors, state-level officers, and regional officers, FDA has postponed the inspection of facilities in domestic and foreign countries. The FDA compliance team is using this time to perform online surveillance of digital platforms and corresponding documentation instead. 

When would the FDA inspections resume? 

The world is going through a tough time because of the COVID-19 pandemic. As we know, research scientists are working to find a Vaccine or consistently better tools for diagnosis of COVID-19 in the US as well as all over the world; FDA is also focussing its workforce to regulate the medical products that help detect and fight the COVID19 epidemic. Onsite domestic and international inspections are proposed to be resumed from sometime in April this year, depending on the COVID-19 pandemic status.  

Background: FDA Inspection types –

  • Pre-Approval Inspections

These are conducted after a company submits an application to the FDA to market a new medical device.

  • Routine Inspections

Theseare mandated by law every few years for class II and class III device manufacturers.

  • Compliance Follow-Up Inspections

These are the review actions taken by a firm/manufacturer in response to a previous inspection that resulted in significant 483 observations or a Warning Letter.

  • “For Cause” Inspections

These are to investigate a specific problem that has been reported to the FDA. The source of the report can be the manufacturer (e.g., the result of a recall, MDR), user complaints, or even a disgruntled employee.

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