- August 25, 2020
As a safety measure, FDA will pre-announce all inspections, except for retail tobacco inspections, for the foreseeable future. The announcement comes nearly two (2) months after the Agency said it will implement a phased approach to restarting surveillance inspections and four (4) months after the agency halted its domestic inspection program.
However, FDA Commissioner Stephen Hahn said that resuming on-site inspections, “…will depend on the 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…” and added that moving to the next phase would require a downward trend in COVID-19 cases and hospitalizations.
FDA said it will prioritize which inspections it conducts in the coming months using a new risk assessment system to determine the state- and county-level risk posed by the virus. FDA says the risk level will determine what types of regulatory activities the Agency and its partners carry out at the county level: “Mission critical inspections only, all inspections with caveats to help protect staff who have self-identified as being in a vulnerable population and resumption of all regulatory activities.”
Hahn said the Agency will rely on both White House and Centers for Disease Control and Prevention (CDC) guidelines to steer its inspections operations and protect its staff from being exposed to the virus. “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 CDC guidance,” Hahn said.
Hahn also touted FDA’s efforts over the last several months to continue its oversight of regulated industry by alternative means. “We have had great success by using a number of tools as part of the Agency’s risk-based approach to ensuring quality, including remote assessments and import alerts as well as other compliance requirements,” he said.
REFERENCE: RAPS (Regulatory Focus); 10 JUL 2020; Michael Mezher