loader

Are you prepared for a virtual FDA Inspection?

In response to the COVID-19 public health emergency, the FDA is limiting unnecessary contact by only conducting prioritized domestic facility inspections and those that are deemed mission critical.  The FDA is using other avenues to support regulatory decisions and oversight of facilities.  The FDA calls this a remote interactive evaluation.

Download the Emergent 483 FDA Report

Click here to download a copy of the Emergent Manufacturing Operations’ FDA 483 Report. This report details the observations made during the inspection of the vaccine substance manufacturing company.

Use promo code emergent-483 at checkout to download your free copy.
Download Now

Remote Interactive Evaluation

A remote interactive evaluation, or virtual inspection, is a combination of the FDA requesting documents, livestreaming with the facility, and scheduling interviews with key personnel.  A remote interactive evaluation is not the same as an inspection as described in section 704(a)(1) of the FD&C act nor does it constitute an inspection for purposes of section 510(h)(4) of the FD&C act.  The FDA will apply the same risk management approach to determining when a remote interactive evaluation is necessary as it does with inspections.  If the FDA deems a remote interactive evaluation necessary, they will contact the facility by electronic correspondence or phone call.

virtual inspection FDA

Once a facility agrees to the remote interactive evaluation then the FDA will schedule a virtual meeting to discuss the logistics, responsibilities, and expectations.  The FDA will not issue a form 482, Notice of Inspection or issue a form 483, Inspectional Observations.  However, they will issue a report of their findings from the remote interactive evaluation.  They also expect the facility to respond within 15 US business days. The results of the remote interactive evaluation will be used to prepare for and conduct the actual inspection.  The remote interactive evaluation report may be subject to a disclosure request under the Freedom of Information Act (FOIA).

Preparing for the Evaluation

Preparing for the remote interactive evaluation is similar to preparing for an FDA Inspection (see our FDA Inspection Prep Kit), with some additional considerations.

  • Internet Capabilities – since the virtual inspection will be conducted virtually, you’ll need to make sure you have a stable internet connection.
  • Virtual tour – the FDA may request a pre-recorded tour or a livestream tour of your facility.  How will you record this, using your phone camera or a real camera?  If you are livestreaming, do you have sufficient service throughout your facility to accommodate this?
  • Paper documents – Are most of your documents still in paper form?  Consider converting the most frequently requested documents into PDFs.  Refer to our Documentation Checklist for the most frequently requested documents during an FDA inspection.

For more information on how remote interactive evaluations will be conducted and additional ways to prepare, refer to the FDA Guidance for Industry Remote Interactive Evaluations for Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency, April 2021.

Stay in Compliance!  Subscribe to GMP Trends® today.

Leave a Reply

Your email address will not be published. Required fields are marked *