03/23/2026
Photo by QArea Inc. on Unsplash
On December 19th, 2025, the US Food and Drug Administration released the finalized guidance for industry: Processes and Practices Applicable to Bioresearch Monitoring Inspections. The guidance details the processes and practices of Bioresearch Monitoring Program (BIMO) inspections of FDA-regulated establishments NOT specified in existing FDA guides or manuals.
The guidance provides background information about the BIMO program, and its role in maintaining quality and integrity of data and in safeguarding the rights, safety and wellbeing of participants.
The BIMO Compliance Programs are explained with the 11 Compliance Program Manuals (CPGMs) linked on the website. Each CPGM is linked to a particular group for which the FDA is responsible for enforcing applicable regulations in their jurisdiction. There are CPGMs specific to Sponsors and CROs, Investigators, IRBs, among other areas including nonclinical labs and post-marketing safety reporting.
Some of the key information provided by this Guidance:
FDA refers to the stakeholder being inspected as “site”. This is not limited to clinical sites but those stakeholders in the BIMO jurisdiction, e.g., sponsor, clinical investigator, ethics committees.
Inspections can be comprehensive or directed, focusing only on certain operations. Different types of BIMO inspections include:
To support the review of specific submissions or marketing applications,
Routine periodic inspections of ongoing activities,
Or for cause inspections for potential noncompliance and safety issues.
International inspections are also covered and may be conducted in conjunction with other international regulatory partner agencies depending on the location of the study site.
FDA notes that they usually come onsite to the establishment for inspection, but can also use other oversight tools, such as Remote Regulatory Assessments (RRAs) which under the BIMO Program may consist of Remote Interactive Evaluations and requests for records or other information subject to inspection in advance of or in lieu of such inspections (For more information on RRAs, see our previous blog on the subject here). These oversight activities can lead to inspection.
Best practices for stakeholders to follow before, during and after an inspection are outlined in the following section of the guidance and are summarized below.
Importance of Pre-announcement Notice and Communication:
FDA values preannouncement. Preannouncement of an inspections allows the FDA to confirm the location for inspection, what records will need to be available for review, and which personnel will need to be present during the inspection. Exception to preannouncement is if FDA feels it will negatively impact the purpose of inspection.
During preannouncement communications the FDA regularly shares names, titles, and contact information, however, they may not always give the reason for conducting the inspection. If they decide to withhold this information in the pre-announcement, FDA investigators may inform the site’s representative that additional details will be shared during the opening meeting.
The FDA advises that site staff acknowledge and respond to the pre-announcement with confirmation of arrival details and provide contact phone number all within a reasonable time. The guidance notes that FDA does not believe that a lack of acknowledgement/response to the pre-announcement is a reason to delay the start of an inspection.
During the pre-announcement the FDA will communicate the intended duration of the trial including the working hours.
Communication During an Inspection:
FDA includes that the length of an inspection varies depending on multiple factors such as availability of staff, the complexity of the trial, and if observations are noted.
During an inspection, when the FDA personnel request records and other information, the site will have the chance to ask clarifying questions as well as discuss the nature, process, and timeline of the request. It should also be discussed at this time (if not covered in pre-announcement correspondence) the details of any electronic information systems at the site and how the FDA investigators will be given access. FDA are interested in understanding the technical capabilities of the electronic sharing system and in reviewing the electronic audit trails. Copies from these electronic systems may be requested to be shared with the FDA through either a file staring platform, electronic storage media (ex. SSD, USB, memory card etc.), or paper copies as appropriate.
The site should be ready to provide the requested information in a timely manner.
At the end of the inspection, there will be a closeout meeting with the FDA investigators and establishment representatives to discuss findings from the inspection and have the chance to respond to and potentially clarify any of findings.
At the end of an inspection, the FDA may issue a notice of inspectional observations with a Form FDA 483 if the inspector finds any instances on serious noncompliance to regulation. The notice will detail what was observed and what specific regulation(s) the observation(s) is in violation of. Within these notices, there will be a communicated the deadline that FDA expects the recipient to respond to the observations. Communication after Inspection:
In cases where “observations of objectionable conditions and practices” are identified during an inspection the FDA will issue a written Form FDA 483 notifying the site’s top management of the observations. The FDA encourages establishments to respond to these 483s within 15 U.S business days.
In the guidance FDA notes that inspection observation responses need to be carefully written so that they (as applicable):
Address each observation separately,
Note whether the establishment agrees or disagrees, and, why, if the establishment disagrees,
Provide completed and/or planned corrective and preventive actions and corresponding timelines,
Provide a method of verifying or monitoring the effectiveness of the actions,
Submit documentation (e.g., training, Standard Operating Procedures (SOPs), corrective action plans, records, etc.) which supports the response to the observation.
Based on the response, and all other information received and evaluated pre, during and after the inspection, the FDA writes an Establishment Inspection Report (EIR). In it the FDA will determine the classification of the inspection and publicly post the inspection results. The guidance defines the three classifications:
NAI: No Action Indicated, which means no objectionable conditions or practices were found during the inspection,
VAI: Voluntary Action Indicated, which means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action or,
OAI: Official Action Indicated, which means regulatory and/or administrative actions are recommended.
Who to Contact at FDA for More Information:
This final section of the guidance directs sites who have unresolved questions or concerns to the applicable FDA personnel.
Inspection preparedness can be a big lift. Inspection readiness is a mindset as much as a process, like risk management.
If you would like support regarding FDA BIMO inspections, Clinical Pathways has expert processes and tools for inspection readiness and hosting of inspections. Clinical Pathways also has training services that can bring you and your company up to speed about all things BIMO. We can provide comprehensive inspection preparedness support throughout the entire product development to stay proactively ready for inspection.
For a full list of our services please see our website, online store and course catalog, and while you’re there, sign up for our free newsletter and blog to stay up to date on clinical trial related news such as this.
-The Clinical Pathways Team
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