Back in March 2023, we noted in our blog that FDA had committed to developing guidance for industry on BIMO inspections.  The draft guidance, titled Processes and Practices Applicable to Bioresearch Monitoring Inspections, was released last week. It's short - about 9 pages of content, heavily footnoted - and focused on logistical aspects of inspections rather than inspectional approach.  When finalized it will replace the Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors:  FDA Inspections of Clinical Investigators and Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors: FDA Institutional Review Board Inspections.

The draft guidance starts with the regulatory basis for FDA's authority to conduct inspections and Remote Regulatory Assessments. It notes that Remote Regulatory Assessments may include both Remote Interactive Evaluations (essentially, remote inspections) and other records requests. The subtext:  if FDA requests records in advance of or in lieu of an inspection, compliance is not optional. 

The guidance then references FDA internal procedures governing inspections, including the Investigations Operations Manual (IOM), the Regulatory Procedures Manual (RPM), and the BIMO Compliance Program Manuals (CPMs).  A Resource Guide at the end of the draft links to these documents, to the BIMO Inspection Metrics reports, and to the search page for FDA Guidance Documents. Buried in a footnote is also a useful link to a statement on FDA's website regarding its information-sharing arrangements with foreign government agencies.

The section on Best Practices for Communication between the FDA and Industry in Advance of, During, or After an Inspection emphasizes common-sense measures for communicating with FDA after an inspection announcement, including arranging start dates and times, discussing the scope of the inspection, and ensuring availability of staff and records. In our experience, FDA inspectors are reasonable about these matters up to the point where they feel they are being stonewalled, a position echoed by the guidance, which warns sponsors that FDA may have good reason for withholding information about an inspection scope or duration. The short statement on FDA's access to electronic systems - "FDA personnel can view electronic records via read-only access or other methods" - will do nothing to address the dozens of questions QA teams have on this topic.

A subsection on communication after an inspection describes the process of issuing the 483 and notes that inspectees are encouraged to provide written responses within 15 days of the end date of the inspection; the agency will take those responses into account "before further Agency action or decision."  FDA strongly suggests that responses to findings should acknowledge the finding; note whether the inspectee agrees or disagrees with the finding, and why; and describe the organization's commitment to addressing the finding, including details and evidence of completed corrective and preventive actions, and timelines for planned actions.

Not addressed in the guideline:

1. The inspector has asked to go to the bathroom.  Is this a trick?  If I don't escort them, will we get a 483?
2. If an inspector eats six pomegranate seeds during an inspection, will they be doomed to wander our basement records room for six months out of the year?
3. When will this inspection end?

(Answers:

1. This is a clever ruse. Be sure to point out the surveillance cameras in the restroom to reassure them that the facility is secure.
2. Yes. Don't feed the inspectors.
3. When your soul leaves your body.)