FDA Update February 10, 2022

Warning – FDA could be knocking on your door!

The FDA Restarts Routine Domestic Surveillance Inspections

With the decline of Covid-19 cases across the country, the FDA has decided to re-start their routine domestic surveillance inspections in the US. The FDA will also resume their foreign surveillance inspections provided that the countries considered are on the CDC’s Level 1 or Level 2 COVID-19 travel list.  The FDA is also planning to inspect those foreign countries not currently on the travel list with the hope to restart that process in April 2022.

The FDA had stopped their on-site inspections on December 29, 2021 due to significant spread of Omicron variant. The intent was to protect their employees and the firms they regulate.  This was initially to continue through January 19, 2022 but the rapid and continuing spread of omicron led to an extension through February 4^th. The FDA just announced the inspection activities will restart as of February 7^th.

While in remote mode, the FDA has continued to use its alternative tools and remote evaluations to provide effective control of tobacco, medical products, food, and drugs as well as continuing to perform mission-critical domestic and foreign inspections.

With the Covid crisis, there are many “NEW” manufacturing companies that have never experienced an FDA inspection. If you are one of these companies and/or concerned that your company has gotten off track with the lack of FDA oversight, it may be a good idea to have a MOCK FDA inspection to check on your QSR/cGMP compliance prior to going through an actual FDA inspection. Remember – for foreign companies, one violative FDA inspection can already lead to being blocked from importation.

For companies that are not familiar with FDA inspections, having a consultant to assist your company prior to and during the FDA inspection maybe the best way to assure a good inspection outcome.

If you do have an inspection that ends in the issuance of a 483 (the FDA’s list of observations), knowing how to respond to the FDA concerns could be critical to showing the FDA your compliance and for foreign companies preventing the possible blacklisting of your products entering the USA market.

If you have any questions or would like to discuss mdi’s over 100 years of FDA inspectional expertise and 483 responses, do not hesitate to contact us.

For more information on dealing with FDA inspections and 483 responses, email us at: [email protected] and RE: FDA Inspections