Earlier today, FDA Commissioner Scott Gottlieb, M.D., made publicly available for the first time FDA’s internal policy (MAPP 5014.1) for how drug manufacturing facilities are prioritized and scheduled for surveillance inspections. According to the press release, in 2017, approximately 5,063 drug establishments were subject to routine surveillance inspection; out of these approximately 5,063 eligible drug establishments, FDA conducted 1,453 drug surveillance inspections. Accordingly, this site selection policy (and the accompanying Site Selection Model (SSM)) is intended to clarify how FDA prioritizes inspections of sites that pose the greatest potential risks to patients. While certain elements of this policy could be gleaned from prior public statements or presentations from FDA regarding the agency’s risk-based inspectional strategies and resource allocation, the announcement is significant in that it memorializes in a formal policy document FDA’s approach for prioritizing and scheduling surveillance inspections.

Key takeaways from this policy document include:

  • FDA’s Office of Surveillance is responsible for maintaining and applying the SSM, and generating a Site Surveillance Inspection List (SSIL). FDA’s Office of Regulatory Affairs is responsible for planning and conducting inspections based on the SSIL.
  • The SSM will be applied equally to domestic and foreign establishments. FDA’s goal is “to achieve parity in inspection frequency, meaning equal frequency for sites with equivalent risk, regardless of geography (foreign or domestic).”
  • To further FDA’s Mutual Recognition Agreement with the EU, the SSM will consider whether a particular establishment has been inspected by a foreign regulatory authority determined to be capable by FDA. (We most recently discussed FDA’s recognition of inspectional data from EU regulatory authorities here).
  • Manufacturing sites on OAI status and manufacturing sites currently on Import Alert are not included in FDA’s surveillance inspection planning; these sites are subject to inspection according to FDA’s enforcement policies.
  • Drug quality matters. A key risk component in the SSM is hazard signals, including Field Alert Reports, Biological Product Deviation Reports, MedWatch reports, and recalls. Indeed, based on our recent experience, hazard signals may be the key risk component for moving up FDA’s SSIL.
  • Newly registered sites should expect to be inspected within 30 days after registering with FDA.

In addition to the implicit exclusions from the SSM noted above (i.e., sites on OAI status), certain establishments are expressly excluded from the SSM, including registered outsourcing facilities, medical gas sites, inactive ingredient manufacturers, and manufacturers of drugs intended for use only in clinical trials.