SOP-702
FDA Inspections and Remote Regulatory Assessments
- Number
- SOP-702
- Category
- Quality Assurance
- Edition
- Reference Edition 1.3
- Approx. pages
- 10
[YELLOW] the site fills in. [DEFAULT: green] a value the site may keep or change.
On this page
1. Purpose
This SOP describes how [SITE NAME] stays ready for, hosts and responds to FDA Bioresearch Monitoring (BIMO) inspections of clinical investigators and FDA Remote Regulatory Assessments (RRAs).
2. Scope
This SOP applies to every FDA inspection or RRA of a study conducted at [SITE NAME], whether routine (study-oriented, usually linked to a marketing application) or for-cause, for drug, biologic and device studies. It applies to all locations and all staff. It also applies when the site is inspected as a sponsor-investigator (SOP-800 Sponsor-Investigator Responsibilities (IND/IDE Holder)).
It does not cover sponsor and IRB audits (SOP-701 Sponsor and IRB Audits) or inspections by other agencies (for example, DEA, state health departments, CLIA surveyors). The site may adapt sections 5.4 to 5.6 for those.
Where the clinical trial agreement (CTA), the sponsor or the IRB sets a stricter requirement (for example, a shorter notification time), follow the stricter requirement.
3. Responsibilities
| Role | Responsibilities |
|---|---|
| Principal Investigator (PI) | Must permit FDA to access, copy and verify study records (21 CFR 312.68; 21 CFR 812.145). Is available during the inspection, receives the Form FDA 482 and Form FDA 483, attends the opening and close-out meetings, and signs the written response. |
| Site Director | Is the site's management representative, decides whether to involve legal counsel, provides resources, and approves any departure from this SOP during the inspection. |
| Quality Lead | Is the inspection liaison unless another person is named, keeps the request log, runs daily wrap-ups, and leads the 483 or RRA response and CAPA. |
| Regulatory Coordinator | Notifies the sponsor and IRB, prepares regulatory records, and makes and logs copies. |
| Lead CRC / Clinical Research Coordinator (CRC) | Retrieves participant records, answers questions about their own work, and supports the back room. |
| Research Pharmacist or IP Manager | Presents IP storage, temperature and accountability records. |
| All Research Staff | Cooperate with FDA, answer truthfully and only within their knowledge, and never alter, destroy or hide records. |
4. Definitions
| Term | Definition |
|---|---|
| Inspection | The act by a regulatory authority of conducting an official review of documents, facilities, records and any other resources the authority deems related to the clinical trial. Some aspects may be conducted remotely (ICH E6(R3) Glossary). |
| BIMO | FDA's Bioresearch Monitoring Program. Clinical investigator inspections follow Compliance Program 7348.811, Clinical Investigators and Sponsor-Investigators. |
| FDA investigator | The FDA employee who conducts the inspection. FDA BIMO inspections are carried out by the Office of Inspections and Investigations (formerly the Office of Regulatory Affairs). |
| Form FDA 482, Notice of Inspection | The form the FDA investigator issues at the start of an on-site inspection, with presentation of FDA credentials. |
| Form FDA 483, Inspectional Observations | The form issued at the end of an inspection listing observed deviations from the regulations. Observations that are not regulatory deviations are discussed at close-out but not listed. |
| Establishment Inspection Report (EIR) | FDA's narrative report of the inspection. |
| Remote Regulatory Assessment (RRA) | An examination of an FDA-regulated establishment or its records conducted entirely remotely to evaluate compliance. An RRA is not an inspection. It may be mandatory (a records request under section 704(a)(4) of the FD&C Act) or voluntary (remote records requests and remote interactive evaluations). |
| NAI, VAI, OAI | FDA's inspection classifications: No Action Indicated, Voluntary Action Indicated, Official Action Indicated (section 5.9). |
| Inspection liaison | The staff member who is the FDA investigator's main point of contact and keeps the request log. |
| Back room | A separate room where staff retrieve, check and copy requested records before they go to the inspection room. |
5. Procedure
5.1 Inspection readiness (ongoing)
5.1.1
The Quality Lead keeps an inspection readiness file at [INSPECTION READINESS FILE LOCATION], updated at least [DEFAULT: every 6 months], containing:
- organization chart and list of current staff with roles
- list of active and completed studies still in the retention period, with sponsor, protocol, IND/IDE number, PI and IRB
- current SOP index (F-100-03 SOP Master Index and Review Schedule)
- blank copies of F-702-01 Inspection Request and Document Log
- contact list: sponsor and CRO contacts per study, IRB, [LEGAL COUNSEL], IT support, and the FDA BIMO contacts used at the last inspection
- the site's internal call tree for inspections
5.1.2
The Quality Lead names an inspection liaison and a backup, and records them in the readiness file.
5.1.3
All Research Staff complete inspection readiness training at hire and every [DEFAULT: 2 years], covering this SOP and how to answer questions. Training is recorded on F-103-01 Staff Training Log.
5.1.4
Studies are kept ready for inspection by routine QC and internal audits under SOP-700. A study that supported a marketing application is the most likely to be inspected, often after the study has closed. Archived records must be retrievable quickly (SOP-402 Record Retention, Archiving and Destruction).
5.2 Notification of an inspection
5.2.1
FDA usually pre-announces clinical investigator inspections by telephone or email, unless the assignment says otherwise (CP 7348.811). Any staff member who receives contact from FDA records on F-702-01:
- name, title, FDA office, telephone and email of the caller
- study, protocol, sponsor and PI named
- proposed start date and expected duration
- records or people FDA asks to have available
- whether FDA describes the visit as an inspection or an RRA
5.2.2
The staff member does not commit to anything beyond taking details and tells the caller the PI or Quality Lead will call back the same business day. The staff member informs the PI, Quality Lead and Site Director immediately.
5.2.3
The Quality Lead verifies the caller by calling back through an FDA telephone number or email address obtained independently (for example, from fda.gov), not a number supplied in an unexpected message.
5.2.4
The PI or Quality Lead confirms a start date with FDA. The PI may ask for a reasonable change of date for genuine unavailability. The site must not delay an inspection to gain preparation time. FDA may treat an unjustified delay as a refusal to permit inspection (section 5.5.8).
5.2.5
The Regulatory Coordinator notifies, in writing:
- the sponsor (or CRO), within [DEFAULT: 1 business day of FDA contact] or the CTA timeline if shorter
- the IRB, as required by the IRB's policy
- [LEGAL COUNSEL], when the Site Director decides counsel should be involved. The Site Director should involve counsel for any for-cause inspection or any inspection where the site expects significant findings.
5.2.6
The sponsor may offer support (for example, a sponsor representative on site). The Site Director decides, with the PI, whether sponsor representatives may attend. They do not sit in the inspection room or answer for site staff unless the FDA investigator agrees.
5.3 Preparation
5.3.1
The Quality Lead holds a planning meeting with the PI, Site Director, Regulatory Coordinator and Lead CRC as soon as the date is set.
5.3.2
The study team gathers all records for the study, including:
- Investigator Site File (F-204-01 Investigator Site File Index), protocol versions, IRB approvals and correspondence
- Form FDA 1572 versions (drug and biologic studies) or signed investigator agreements (device studies), CVs, licenses, training records and F-302-01 Delegation of Authority Log
- financial disclosure records (SOP-104 Conflict of Interest and Financial Disclosure)
- original signed consent forms for every participant, F-301-01 Informed Consent Process Notes and F-301-02 Consent Form Version Control Log
- source documents and EHR records, F-303-01 Screening and Enrollment Log and eligibility records
- IP records: F-304-01, F-304-02, F-304-03, shipping and return records
- AE and SAE records, safety reports received and their IRB submissions
- F-308-01 Protocol Deviation Log, F-600-01 Monitoring Visit Log and monitoring follow-up letters
- sponsor correspondence and Notes to File
- equipment calibration and laboratory certification records (SOP-312)
- electronic system access (EDC, IxRS, eConsent, ePRO portals) with read-only accounts for FDA if requested
5.3.3
Staff do not alter records to prepare. Errors found during preparation are corrected under SOP-306 Source Documentation and Data Integrity (ALCOA+) with the current date and reason, or documented on F-306-01 Note to File. Backdating, re-creating or discarding records is prohibited and may be a criminal offense.
5.3.4
The Site Director arranges:
- an inspection room with a desk, chairs, power, internet and a telephone, away from participant care areas and other studies' records
- a back room near the inspection room
- a copier or scanner, and "Copy" and "Confidential" stamps or labels
- read-only, time-limited EHR and system accounts for the FDA investigator if requested, limited to the study's participants (SOP-401 Computerized Systems and Electronic Records)
5.3.5
The Quality Lead briefs all staff on the schedule and on section 5.5.
5.4 Arrival and opening meeting
5.4.1
Reception directs the FDA investigator to the liaison. The liaison greets them and notifies the PI and Quality Lead.
5.4.2
The FDA investigator presents FDA credentials and issues Form FDA 482, Notice of Inspection, to the PI or the most responsible person present. The liaison records the investigator's name and credential number on F-702-01. The liaison does not photocopy FDA credentials. The original Form FDA 482 is filed in the inspection file.
5.4.3
At the opening meeting, the PI gives a short description of the site, the study, and who did what (using the delegation log). The liaison asks the FDA investigator for the inspection scope, the records they want first, the people they want to interview, and the expected schedule.
5.4.4
The site does not ask the FDA investigator to sign confidentiality agreements, visitor waivers or sign-in terms. The liaison may explain safety and infection-control rules for clinical areas.
5.5 During the inspection
5.5.1
Request log. The liaison logs every request on F-702-01: the record requested, time requested, time provided, who retrieved it, whether a copy was given, and any question asked. The liaison asks for clarification of any unclear request.
5.5.2
Providing records. The back room retrieves each record, checks it is the complete and correct record, and gives it to the liaison, who hands it to the FDA investigator. The site provides what is requested, promptly, and does not volunteer unrequested records.
5.5.3
Copies. When the FDA investigator asks for copies, the Regulatory Coordinator:
- makes two identical copies, one for FDA and one duplicate set kept in the inspection file
- marks each FDA copy "Copy" with the date provided, and marks pages containing sponsor or site trade secret or confidential commercial information "Confidential"
- logs each copy on F-702-01
- provides participant records identified by participant ID. For drug and biologic studies, FDA may require identified records when the records of particular individuals need more detailed study, or when there is reason to believe the records do not represent actual case studies or actual results (21 CFR 312.68). For device studies, FDA may require identified records when it has reason to suspect that adequate informed consent was not obtained, or that required reports were not submitted or are incomplete, inaccurate, false or misleading (21 CFR 812.145(c)). HIPAA permits these disclosures to FDA without authorization (45 CFR 164.512(b)(1)(i) and 164.512(d)), and most consent forms also authorize FDA access. The liaison logs any identified records provided.
5.5.4
Interviews and answering questions. All staff:
- answer truthfully, accurately and only within their own knowledge
- answer the question asked, using the records where possible
- say "I don't know" when they don't know, and offer to find the person who does
- do not guess, speculate, give opinions about other people's work, or interpret regulations
- ask for a question to be repeated or clarified if it is unclear
- may correct or add to an earlier answer once they have checked the facts, telling the liaison first
5.5.5
Escorting. The liaison or a delegated staff member accompanies the FDA investigator during facility tours (IP storage, laboratory, archive) and interviews.
5.5.6
Photographs. FDA investigators may take photographs as part of an inspection. Staff do not obstruct the FDA investigator. If a photograph would capture participant identifiers or another sponsor's confidential information, the liaison asks the investigator politely to avoid it, records what was photographed on F-702-01, and, where possible without capturing protected information, takes a matching photograph for the site file. Any objection beyond this is a Site Director decision after consulting [LEGAL COUNSEL], because a refusal may be treated as a refusal of inspection.
5.5.7
Affidavits and signed statements. The FDA investigator may ask a staff member to sign an affidavit (Form FDA 463a) or other statement, usually when significant problems are suspected. Staff are not required to sign. A staff member asked to sign:
- tells the liaison, who informs the Site Director
- may decline politely, or ask for time to read the statement and consult [LEGAL COUNSEL] before deciding
- does not sign any statement that is inaccurate or that they have not read in full
- asks for a copy of anything they sign
5.5.8
Prohibited conduct. No one refuses entry, refuses access to or copying of records FDA is entitled to inspect, delays unreasonably, or alters, destroys or hides records. Refusing to permit an inspection is a prohibited act under section 301(f) of the FD&C Act.
5.5.9
Daily wrap-up. At the end of each day the liaison asks the FDA investigator for any concerns, open requests and plans for the next day. The liaison then holds an internal wrap-up with the PI, Quality Lead and Site Director to review F-702-01, answer open requests, identify possible observations, and start corrections. Corrections made during the inspection are documented under SOP-306 and described at close-out.
5.6 Close-out meeting and Form FDA 483
5.6.1
The PI attends the close-out meeting with the Quality Lead and Site Director.
5.6.2
If FDA observed deviations from the regulations, the FDA investigator issues Form FDA 483, Inspectional Observations, to the PI. Observations that are not regulatory deviations may be discussed but are not listed on the 483. They are reported in the EIR (CP 7348.811).
5.6.3
At the meeting the PI or Quality Lead:
- listens to each observation and asks clarifying questions
- points out factual errors, with evidence
- may describe corrections already made or planned, without promising actions the site has not agreed
- does not argue
- asks where to send the written response
5.6.4
The liaison writes down every observation and every discussion item, including those not on the 483, and files the notes with the 483.
5.6.5
Receiving no 483 does not mean the inspection is classified NAI. The final classification comes later from FDA.
5.7 After the inspection: notification and 483 response
5.7.1
The Regulatory Coordinator sends a copy of the 483 (or confirms that none was issued) to the sponsor within [DEFAULT: 2 business days] or the CTA timeline if shorter, and notifies the IRB under the IRB's reporting policy.
5.7.2
The site submits a written response to the 483 within 15 business days of the date the 483 was issued (normally the last day of the inspection), to the FDA correspondence address given at close-out. The FDA investigator informs the clinical investigator that a written response may be submitted within this time (CP 7348.811). FDA's policy is to conduct a detailed review of a response received within 15 business days before deciding whether to issue a Warning Letter, and not ordinarily to delay a Warning Letter to review a later response (FDA, Review of Post-Inspection Responses, 74 FR 40211, August 11, 2009). The day the 483 is issued is day 0. Business days exclude weekends and US federal holidays.
5.7.3
The Quality Lead drafts the response with the PI. For each observation the response includes:
- the observation restated
- whether the site agrees, with any factual clarification
- the root cause (SOP-703 Corrective and Preventive Action (CAPA))
- the correction already done, with evidence attached (for example, revised log, training record, Note to File)
- the corrective and preventive actions, owners and completion dates
- how the site will check effectiveness, and a commitment to send updates by stated dates
5.7.4
The PI signs the response. The sponsor may review a draft if the CTA requires or the PI agrees, but the response is the PI's. The Site Director arranges review by [LEGAL COUNSEL] where findings could lead to OAI classification.
5.7.5
The response is factual and professional. It does not admit to violations that did not occur, and it does not promise what the site cannot deliver. FDA may release the response under the Freedom of Information Act (FOIA). Information the site considers confidential commercial information or personal privacy information is marked as such.
5.7.6
The Quality Lead opens CAPAs on F-703-01 CAPA Record for each observation (SOP-703 5.1.2), tracks them to closure, and sends any promised updates to FDA on time.
5.8 EIR and post-inspection correspondence
5.8.1
FDA's practice is to provide the inspected party with a copy of the narrative portion of the EIR once the inspection is closed. If the site has not received the EIR within [DEFAULT: 6 months of the inspection], the Regulatory Coordinator requests it from FDA through a FOIA request to FDA's Division of Freedom of Information.
5.8.2
The Regulatory Coordinator files the 482, 483, response, EIR, classification letter and all FDA correspondence in the ISF and inspection file, and sends copies of FDA letters to the sponsor and IRB as required.
5.9 Possible outcomes
5.9.1
FDA classifies each clinical investigator inspection (CP 7348.811):
- NAI (No Action Indicated): no objectionable conditions, or none significant enough to justify further action.
- VAI (Voluntary Action Indicated): objectionable conditions found, but not at the threshold for regulatory action. FDA may send a letter expecting prompt voluntary correction.
- OAI (Official Action Indicated): objectionable conditions found and regulatory action recommended, because participants were or would be exposed to unreasonable and significant risk, participants' rights, welfare or safety were seriously compromised, or data integrity or reliability was compromised.
5.9.2
Following an OAI classification FDA may issue:
- an Untitled Letter
- a Warning Letter, which FDA posts publicly and which requires a written response within the time stated in the letter
- a Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE), which can lead to disqualification from receiving investigational products (21 CFR 312.70; 21 CFR 812.119)
- rejection of study data, or other administrative, civil or criminal actions
5.9.3
Any Warning Letter, Untitled Letter or NIDPOE goes immediately to the Site Director and [LEGAL COUNSEL]. The PI responds within the time stated in the letter. The Site Director informs all sponsors of the PI's active studies as the CTAs require.
5.10 Remote Regulatory Assessments
5.10.1
FDA states when an activity is an RRA and whether it is mandatory or voluntary (FDA guidance, Conducting Remote Regulatory Assessments: Questions and Answers, June 2025). Staff who receive an RRA request handle it as in section 5.2, and the Site Director and Quality Lead decide the response.
5.10.2
Mandatory RRA (records request under section 704(a)(4) of the FD&C Act). Since the Food and Drug Omnibus Reform Act of 2022, FDA may require sites subject to BIMO inspection to provide records or other information in advance of or in lieu of an inspection. The site must provide the records within the timeframe stated in FDA's request. If the site cannot meet the timeframe, the Quality Lead contacts FDA before the due date. FDA does not issue a Form FDA 482 or 483 for an RRA.
5.10.3
Voluntary RRA. FDA may ask the site to take part in remote records review or a remote interactive evaluation (for example, teleconferences, screen sharing, livestream video of facilities). Participation is voluntary, and FDA obtains consent from site management before starting. FDA will not take enforcement action solely because a site declines a voluntary RRA, but a site cannot opt out of an inspection, and declining may lead FDA to inspect instead. The Site Director decides, with the PI, after discussing scope, schedule and technology with FDA, and records the decision on F-702-01. Consent to a voluntary RRA is given by the Site Director or PI only.
5.10.4
Conducting an RRA. The liaison and request log apply as for an inspection, with these additions:
- Records are sent only by the secure method FDA specifies. The Regulatory Coordinator logs each file sent, with date and content, on F-702-01 and keeps an identical copy.
- Before any screen sharing or livestream, the liaison closes all other windows and records and checks that no other participant's or study's information is visible.
- Remote system access for FDA is read-only, limited to the study and time-limited (SOP-401).
- Staff interviews by video follow section 5.5.4.
5.10.5
RRA close-out and response. At the end of an RRA, FDA may hold a close-out meeting and present a written list of RRA observations. The site may respond at the meeting and in writing. FDA encourages a written response within 15 business days and generally considers responses received in that time before deciding on further action. The response follows section 5.7.3. The RRA observation list and the site's response may be disclosed under FOIA. FDA may follow an RRA with an inspection.
5.11 Lessons learned
5.11.1
Within [DEFAULT: 30 calendar days of close-out], the Quality Lead holds a lessons-learned review with the study team and records actions on F-703-01. The results go to the next management review under SOP-700.
6. Related Forms and SOPs
- F-702-01 Inspection Request and Document Log
- F-703-01 CAPA Record
- F-100-03 SOP Master Index and Review Schedule
- F-103-01 Staff Training Log
- F-204-01 Investigator Site File Index
- F-306-01 Note to File
- SOP-104 Conflict of Interest and Financial Disclosure
- SOP-306 Source Documentation and Data Integrity (ALCOA+)
- SOP-400 Participant Privacy and HIPAA in Research
- SOP-401 Computerized Systems and Electronic Records
- SOP-402 Record Retention, Archiving and Destruction
- SOP-700 Internal Quality Control and Quality Assurance Audits
- SOP-701 Sponsor and IRB Audits
- SOP-703 Corrective and Preventive Action (CAPA)
- SOP-800 Sponsor-Investigator Responsibilities (IND/IDE Holder)
- SOP-903 Network Oversight of Member Sites (Metrics, Central QA, Escalation) (Model N only)
- Appendix B Central and Site Responsibility Matrix (Model N only)
7. References
| Reference | Title |
|---|---|
| FD&C Act section 704 (21 U.S.C. 374) | Factory inspection, including 704(a)(4) records requests and 704(a)(5) BIMO inspections |
| FD&C Act section 301(f) (21 U.S.C. 331(f)) | Prohibited acts: refusal to permit entry or inspection |
| 21 CFR 312.62 | Investigator recordkeeping and record retention |
| 21 CFR 312.68 | Inspection of investigator's records and reports |
| 21 CFR 312.70 | Disqualification of a clinical investigator |
| 21 CFR 812.140 | Records (devices) |
| 21 CFR 812.145 | Inspections (devices) |
| 21 CFR 812.119 | Disqualification of a clinical investigator (devices) |
| 21 CFR 20 | Public Information (FOIA) |
| 45 CFR 164.512(b) and (d) | Uses and disclosures for public health (disclosures to a public health authority) and health oversight activities (HIPAA) |
| FDA Compliance Program 7348.811 | Bioresearch Monitoring: Clinical Investigators and Sponsor-Investigators |
| 74 FR 40211 (August 11, 2009) | Review of Post-Inspection Responses |
| FDA Guidance (December 2025) | Processes and Practices Applicable to Bioresearch Monitoring Inspections |
| FDA Guidance (June 2025) | Conducting Remote Regulatory Assessments: Questions and Answers |
| FDA Draft Guidance (October 2023) | Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities |
| FDA Field Management Directive 145 | Release of the Establishment Inspection Report to the inspected establishment |
| ICH E6(R3) Annex 1, 2.3.5 | Investigator permits inspection by regulatory authorities |
| ICH E6(R3) Annex 1, 2.12.14 | Direct access to trial records on request |
| ICH E6(R3) Glossary | Inspection, Direct Access |
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