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FDA Inspection – Procedures, Compliance, and Regulatory Guidelines-11.docx, Exams of Advanced Education

London South Bank University (LSBU)Advanced Education

FDA Inspection – Procedures, Compliance, and Regulatory Guidelines-11.docx

Typology: Exams

2025/2026

Available from 03/11/2026

Toperthetop
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FDA Inspection – Procedures, Compliance,
and Regulatory Guidelines
FDA Inspections: - ANS✔✔ Under the Food, Drug, and Cosmetic Act, the Food
and Drug Administration (FDA) has the power to inspect clinical
investigators, sponsors, contract research organization (CRO), institutional
review board (IRB), and other parties involved in clinical trial conduct.
This is done through the Bioresearch Monitoring (BIMO) program.
The goal of the BIMO program are: - ANS✔✔ 1. To protect the rights, safety,
and welfare of subjects involved in FDA-regulated clinical trials
2. To verify the accuracy and reliability of clinical trial data submitted to FDA
in support of research or marketing applications
3. To assess compliance with FDA's regulations governing the conduct of
clinical trials.
FDA Inspection of sponsor / CRO can occur: - ANS✔✔ 1. On receipt of
marketing application / submission
2. Upon receipt of a complaint / concern
3. For general surveillance
-The inspection is usually requested by the responsible FDA center that
oversees the investigational product submission to the FDA district office
covering the location of the sponsor / CRO.
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FDA Inspection – Procedures, Compliance,

and Regulatory Guidelines

FDA Inspections: - ANS✔✔ Under the Food, Drug, and Cosmetic Act, the Food and Drug Administration (FDA) has the power to inspect clinical investigators, sponsors, contract research organization (CRO), institutional review board (IRB), and other parties involved in clinical trial conduct. This is done through the Bioresearch Monitoring (BIMO) program. The goal of the BIMO program are: - ANS✔✔ 1. To protect the rights, safety, and welfare of subjects involved in FDA-regulated clinical trials

  1. To verify the accuracy and reliability of clinical trial data submitted to FDA in support of research or marketing applications
  2. To assess compliance with FDA's regulations governing the conduct of clinical trials. FDA Inspection of sponsor / CRO can occur: - ANS✔✔ 1. On receipt of marketing application / submission
  3. Upon receipt of a complaint / concern
  4. For general surveillance -The inspection is usually requested by the responsible FDA center that oversees the investigational product submission to the FDA district office covering the location of the sponsor / CRO.

-The inspection is typically study-specific and is usually pre-announced to sponsor / CRO in advance. List of events that may occur during an FDA inspection: - ANS✔✔ 1. Notice of inspection and credentials

  1. Opening interview (and secondary interviews as appropriate)
  2. Records inventory and audit: -Data audit -Records of research subject protection -Control of investigational product(s)
  3. Documentation of findings
  4. Close-out discussion Area of focus during an FDA inspection of sponsor / CRO may include: Personnel and Organization - ANS✔✔ 1. Review of key personnel involved in clinical studies (e.g. organizational structure, CVs, etc.)
  5. What (if any) of the duties and functions are outsourced: -Name of the vendors, contractors, consultants;

Area of focus during an FDA inspection of sponsor / CRO may include: Adverse Event Monitoring / Reporting - ANS✔✔ 1. Review of systems / process for adverse events tracking 2 Reporting of adverse events to regulatory authorities, review boards, and other investigational sites. Area of focus during an FDA inspection of sponsor / CRO may include: Data Handling / Data Verification - ANS✔✔ 1. Procedure and process for data handling (e.g. standard operating procedures)

  1. Data verification (e.g. inquiries, source data verification at site) Area of focus during an FDA inspection of sponsor / CRO may include: Control of Investigational Product(s) - ANS✔✔ 1. Investigational product related documents (e.g. certificate of analysis, batch records)
  2. Shipment records
  3. Blinding procedures and investigational product labeling records
  4. Investigational product accountability, retention, and discard information Area of focus during an FDA inspection of sponsor / CRO may include: Automated Processes (Electronic Systems) - ANS✔✔ 1. Review standard operating procedures (SOPs)
  5. Validation
  1. System security and access control
  2. Availability of audit trails Area of focus during an FDA inspection of sponsor / CRO may include: Record Retention - ANS✔✔ 1. Review standard operating procedures (SOPs)
  3. Review storage and security
  4. Availability of records for review and inspection Area of focus during an FDA inspection of sponsor / CRO may include: After the Inspection - ANS✔✔ At the end of the inspection, if objectionable conditions are observed, FDA inspector will provide the sponsor / CRO with a document, called an FDA Form 483, which includes the name of the sponsor / CRO and the date(s) of inspection, and lists the observations made by the FDA inspector during the inspection. After an FDA Inspection: Establishment Inspection Report (EIR) - ANS✔✔ This report with all attachments, exhibits, and any post-inspection correspondence will be submitted to the FDA center that originated the inspection request. With the exception of instances where procedures indicate that the relevant FDA center has the right of final classification, the final classification of the inspection is made by the FDA district office. An inspection classification reflects the compliance status of the sponsor / CRO at the time of the inspection, based on the observations documented.

FDA Warning Letter (WL): - ANS✔✔ A Warning Letter is a formal notification that allows prompt voluntary corrective action to be taken. The sponsor / CRO must provide formal respond to the Warning Letter within a specified time allowed. Warning Letter is also public information that will be posted on FDA website. FDA Inspection of Clinical Trial Site: - ANS✔✔ FDA conducts clinical trial site inspections to determine if the conducting of the clinical studies is in compliance regulatory requirements. Investigators who conduct FDA-regulated clinical trials are required to permit FDA investigators to access, copy, and verify any trial related records or reports Possible reasons behind an FDA inspection of a clinical trial site: - ANS✔✔ 1. To verify the accuracy and reliability of data that has been submitted to the agency

  1. A complaint to the agency about the conduct of the study at a particular investigational site
  2. In response to sponsor concerns
  3. Upon termination of the clinical site
  4. During ongoing clinical trials to provide real-time assessment of the investigator's conduct of the trial and protection of human subjects
  1. At the request of an FDA review division
  2. Related to certain classes of investigational products that FDA has identified as products of special interest in its current work plan (i.e., targeted inspections based on current public health concerns). Preparation for the FDA Inspection: - ANS✔✔ 1. Document any correspondence(s) that occurs between the FDA inspector and the study staff
  3. Notify study staff, sponsor, and IRB
  4. Ensure that the medical records for all subjects are available for review
  5. Review study documentation to ensure: -Accuracy and completeness -Outstanding issues are resolved and documented. Events that may occur during an FDA site inspection: - ANS✔✔ 1. Notice of inspection and credentials
  6. Opening interview (and secondary interviews as appropriate)
  7. Records inventory and audit: -Data audit

documents were signed by the subject or the subjects' legally authorized representative prior to entry in the study Areas of focus during an FDA inspection of clinical trial site may include: Data Collection - ANS✔✔ 1. How the study data were obtained and where the study data were recorded

  1. Audit of case report forms and supporting source documentation including signed and dated consent forms and medical records including, for example, progress notes of the physician, the subject's hospital chart(s), and the nurses' notes. Areas of focus during an FDA inspection of clinical trial site may include: Investigational Product Accountability - ANS✔✔ Accountability for the investigational product, including shipping records and disposition of unused investigational product Areas of focus during an FDA inspection of clinical trial site may include: Financial Disclosure - ANS✔✔ Whether the clinical investigator disclosed information regarding his financial interests to the sponsor and/or interests of any sub-investigator(s), spouse(s) and dependent children Areas of focus during an FDA inspection of clinical trial site may include: Clinical Trial Oversight / Monitoring - ANS✔✔ 1. The monitor's communications with the clinical investigator
  2. The monitor's evaluations of the progress of the investigation
  3. Regulatory correspondence or sponsor and/or monitor correspondence.

Areas of focus during an FDA inspection of clinical trial site may include: Electronic Data - ANS✔✔ Whether or not 21 CFR 11 requirements have been met Areas of focus during an FDA inspection of clinical trial site may include: Adverse Events - ANS✔✔ Whether prompt and complete reporting of adverse events to the IRB and sponsor Areas of focus during an FDA inspection of clinical trial site may include: Record Retention - ANS✔✔ Whether record retention was done following the protocol and regulatory requirements Areas of focus during an FDA inspection of clinical trial site may include: After the Inspection - ANS✔✔ 1. A FDA form 483 may be given to the investigator.

  1. The Establishment Inspection Report (EIR) with inspection classification (OAI, VAI, or NAI) will be provided to the investigator.
  2. A Warning Letter (WL) may be issued for more serious issue observed.
  3. In the case where serious noncompliance was observed, FDA may proceed with the disqualification of the clinical investigator by issuing a Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE). NIDPOE is the start of the legal proceeding process for disqualification of investigators who are repeatedly or deliberately non-compliance to regulations and / or had committed fraud.