On July 10, 2020, the FDA announced that it would resume routine domestic inspections, which had been on pause since March due to the COVID-19 pandemic. During the SFA's regulatory conference call, Monday, Jeni Rogers Lamb of PSL Law Group spoke about how the FDA plans on resuming these inspections and what to expect in this “new normal.”
In a July 10th statement, the FDA said that it would resume its regular inspections starting the week of July 20, based on an advisory level framework that determines when and where it is safest to conduct them. The COVID-19 Advisory Rating system is based on three metrics: the phase of the state based on White House guidelines, the current trend of infection at the county level, and the intensity of infection at the county level.
The system then categorizes companies into three levels, which will mean, either: a continuance of mission-critical inspections only; resuming inspections with caveats to help protect staff who have self-identified as being in a vulnerable population; or resumption of all regulatory activities.
“It’s hard to know what category you’re going to call into at this point,” said Rogers. However, it is important to note that for the foreseeable future, the FDA will be pre-announcing all domestic inspections. Companies will get either a phone call or email notifying them of when an inspection is scheduled, which will help ensure the facility has the appropriate employees on hand to facilitate the inspection.
With that in mind, Rogers strongly advises companies to revisit their FDA inspection policy, especially in regards to who has been identified as part of the inspection team. If those parties are working remotely, it’s important to figure out how to bring them into the plant environment in a safe way.
In addition, even though routine inspections were suspended through July 20, the FDA has continued to enforce both food safety and food labeling regulations, said Rogers. As consumers are staying at home and sourcing more food online, Rogers recommends that companies make sure that their online presence is compliant as possible.
Listen to the full recording now.
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