July 17, 2020
In March, 2020, the U.S. Food and Drug Administration (“FDA”) announced that the Agency would temporarily halt domestic facility inspections not deemed “mission-critical,” citing health concerns related to the COVID-19 pandemic. On July 10th, FDA announced its plans to resume domestic on-site facility inspections during the week of July 20th.
With the re-start of on-site inspections, the Agency is following both White House Guidelines and CDC guidance to optimize its operations and ensure employee safety. FDA is employing a new COVID-19 rating system, called the “COVID-19 Advisory Level,” to evaluate “when and where it is safest to conduct prioritized domestic inspections.” This rating system evaluates the number of COVID-19 cases in a particular area using state and national data. A locality’s COVID-19 Advisory Level is based on the phase of the particular state, as defined by White House guidelines, as well as statistics on infection trends and intensity, evaluated at the county level.
Depending upon a particular county’s COVID-19 Advisory Level, the Agency intends to take one of three actions: (1) pursue mission critical inspections only; (2) perform inspections, with precautions in place to protect vulnerable staff members; or (3) resume normal regulatory activities.
FDA also announced that for the foreseeable future, on-site inspections (other than retail tobacco inspections) will be pre-announced to FDA-regulated businesses. According to FDA, this will promote the safety of both the FDA investigator and the company’s employees, and give companies a “heads up” to ensure that employees essential to the inspection are present when the investigator arrives. FDA investigators will be equipped with personal protective equipment to ensure inspections resume as safely as possible.
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