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On October 29, the FDA rolled out an updated agreement between CDER and the Office of Inspections and Investigations (OII), formerly the Office of Regulatory Affairs. The actual PDF is here.
It sets out how the two entities coordinate marketing application assessments, inspections, and related compliance activities for human drugs. The document, Integration of FDA Facility Evaluation and Inspection Program for Human Drugs: A Concept of Operations, took effect on October 21, 2026, and supersedes the original June 2017 version.
It covers preapproval, postapproval, surveillance, and for-cause inspections, but not pharmacy compounding or bioresearch monitoring.
To be clear, this isn’t guidance. It’s an operating agreement between FDA offices, so it describes how the agency intends to work rather than setting expectations for manufacturers and the industry. That said, it still shows how the FDA decides whether to inspect, who leads, and how quickly findings reach a final classification, so it’s worth parsing.
We have some thoughts and recommendations at the end, too.
What’s new here
A couple of things to mention:
Remote regulatory assessments (RRAs). If you’re not familiar with RRAs, they’re either an assessment of records or other information an establishment submits at FDA’s request under section 704(a)(4) of the FD&C Act, or a remote interactive evaluation, such as livestreamed video of operations, teleconferences, or screen sharing. The FDA says it intends to take a risk-based approach to deciding whether to initiate or request one. This document is explicit that RRAs conducted under 704(a)(4) don’t satisfy inspection requirements under section 704(a)(1), because there’s no physical entry. It also says RRAs can help the agency fulfill its regulatory responsibilities. Both OII and CDER may lead them.
Mutual Recognition Agreement (MRA) inspection reports. The FDA says it may use recent inspection reports from MRA partners, such as those under the agreements with the EU, Switzerland, and the UK, to assess CGMP compliance and support establishment recommendations for applications. Unlike 704(a)(4) assessments, MRA inspection reports can fulfill the inspection requirements under section 510(h).
This revision also aligns roles with FDA’s October 2024 reorganization. Stated aims include reducing redundancy between the CDER and OII offices and meeting user-fee commitments.
Who’s leading what now
We’ve untangled this in as simple terms as possible.
The CDER conducts preapproval evaluations while OII generally leads preapproval inspections (PAIs), with CDER participating when appropriate.
The PAI process for biological product applications, where CDER generally leads, is unchanged. OII also leads postapproval inspections (PoAIs), again with CDER participating when appropriate.
CDER generally leads RRAs that support either type.
OII leads surveillance inspections, with CDER participating when OII requests it. It inspects establishments prioritized by CDER’s risk-based site selection model.
OII also leads for-cause inspections, which CDER’s Office of Compliance (OC) or Office of Pharmaceutical Quality (OPQ) generally initiate.
For classification, OII’s Office of Human and Animal Drug Inspectorate (OHADI) makes final No Action Indicated (NAI) calls on PAIs and surveillance inspections.
CDER makes the final Voluntary Action Indicated (VAI) and Official Action Indicated (OAI) calls.
The Office of Pharmaceutical Manufacturing Assessment (OPMA) handles them for PAIs, and the Office of Manufacturing Quality (OMQ) handles them for surveillance inspections.
How a PAI decision gets made
Let’s run through the sequence of events the FDA lays out here:
When an application is submitted, an Integrated Quality Assessment (IQA) team of OPQ assessors is assembled.
OPMA runs an initial establishment risk assessment using the application, the site’s inspection history (including MRA inspections, if available), quality intelligence from the Office of Quality Surveillance (OQS), and information from OHADI and OMQ.
The OPMA assessor, with IQA input, then decides whether an inspection is needed.
If the answer is yes, and a PAI goes ahead, the IQA team identifies areas of concern from the application, and those go to the inspection lead through OHADI’s Preapproval Manager.
The inspection team and IQA team keep each other fully apprised of any issue either one uncovers.
If OPMA decides a PAI isn’t necessary, it may conduct an RRA to address outstanding concerns, and it continues to monitor the site’s CGMP status as it relates to the pending application.
The clocks after an inspection
For every inspection type, the complete Establishment Inspection Report (EIR) package is due within 45 days of the inspection’s close.
After that, a few things can happen:
For PAIs with a VAI or OAI recommendation, OPMA makes the final classification through a risk-based assessment of the complete EIR package and the establishment’s written response to the Form 483. It does so within 45 days of receiving both or by the application-related due date, whichever comes first. That classification determines whether the site is adequate to support approval.
For surveillance inspections:
For a potential OAI, OHADI notifies CDER as soon as practical and within two days of the close at most. NAI letters go out within 90 days of the close.
For initial VAIs and OAIs, OMQ makes the final classification and issues a decisional letter within 90 days of the close. Final VAI letters include the EIR. OAI establishments don’t receive the EIR with their classification letter, and OMQ may hold it until it decides on action. For final OAIs, OMQ takes appropriate action within three months of the letter. For-cause inspections with VAI or OAI outcomes follow this same process. Classification letters may be withheld when multiple FDA centers or programs are involved and the findings have different regulatory implications across them.
For PoAIs, OPMA completes a final assessment and recommendation in the 45 days after the EIR package, then initiates follow-up in the next 10 days.
What the FDA will bring to a surveillance inspection
OQS maintains the CDER Facilities Catalog and a Site Selection Model that ranks establishments by risk each year.
On request and ahead of a scheduled inspection, OQS prepares a Site Dossier. Dossiers depend on scheduling and resource capacity, and each includes, but isn’t limited to, the site’s:
Inspection history
Recalls
Shortages
Customer complaints
Foreign regulatory inspection outcomes
Field Alert Reports or Biological Product Defect Reports
… and a list of all drug products made there
After classification, OQS analyzes trends across establishments, products, and regions and uses that analysis to pick key areas of coverage for a site’s next inspection.
What this means for industry teams
A few things you might want to consider in light of the updated operating agreement, here.
Treat remote assessments as part of FDA's oversight process, not as substitutes for on-site inspections. RRAs now appear across all four inspection models, although their intended uses differ. For surveillance, FDA specifically identifies remote quality-system assessments as an option when an on-site inspection is not feasible within the fiscal year, including at establishments in areas subject to significant travel warnings. When OPMA decides a PAI isn’t needed, it may still run an RRA to address outstanding concerns. Significant findings from a postapproval RRA go to OC or OQS, which may then initiate a for-cause or surveillance inspection, so they’re just as consequential. And a 704(a)(4) quality systems assessment, while not an inspection, can influence the scheduling and priority of inspections. If you don’t have a defined process for answering 704(a)(4) records requests and supporting remote interactive evaluations, start with FDA’s June 2025 RRA questions-and-answers guidance. It gives you a great baseline to “backward engineer” into a process. We’ve also written on RRAs here.