FDA plans to resume domestic inspections
The U.S. Food and Drug Administration (FDA) is preparing to resume domestic inspections with a new risk assessment system, from the week commencing 20th July.
The decision to postpone on-site surveillance inspections in the United States was first announced in March. However, since this announcement, the organisation has continued to conduct critical inspections and other activities to ensure FDA-regulated industries were meeting the necessary FDA requirements through the use of tools and remote assessments. During this time, the FDA has been reviewing the safety of many consumer products such as hand sanitiser and diagnostic tests.
In order to determine when and where is safest to conduct the prioritised domestic inspections, the FDA has developed a rating system – the Covid-19 advisory rating system (Covid-19 advisory level). This system uses real-time data to qualitatively assess the number of Covid-19 cases in a local area based on state and national data. The advisory level data will be made available to state partners who carry out inspections of FDA-regulated entities on the agency’s behalf under contract.
The advisory level is based upon the outcome of three metrics:
- Phase of the State (as defined by the White House guidelines)
- Statistics measured at the county level to gauge the current trend
- Intensity of infection
When each of these factors is taken into consideration, the FDA will identify regulatory activities that can occur within the given geographic region. The three main categories of regulatory activity at the county level will be:
- Mission critical inspections only
- All inspections with caveats to help protect staff who have self-identified as being in a vulnerable population
- Resumption of all regulatory activities
Whether prioritised domestic inspections are resumed will be dependent on data about the virus’ trajectory in a given state and locality, and the rules and guidelines that are put in place by state and local governments.
For the foreseeable future, prioritised domestic inspections will be pre-announced to FDA-regulated businesses. The reasoning for this is to help assure the safety of the investigator and the firm’s employees and provide the safest possible environment to accomplish regulatory activities, while also ensuring the appropriate staff are on-site to assist FDA staff with inspection activities. However, please note that due to the nature of retail tobacco inspections, these inspections will not be pre-announced when they resume.
The FDA statement concludes: “The health, safety and wellbeing of our investigators, as well as the public, are of the utmost importance to us. We will ensure our investigators are outfitted with personal protective equipment and are equipped with other necessary equipment to carry out their work while adhering to state and local guidance as well as applicable Centers for Disease Control and Prevention guidance. We will continue to work to ensure our prioritised domestic inspections resume appropriately and as safely as possible.”