SOP for BIMO Inspection Preparation and Response Strategy (FDA Specific)

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Published on 21/12/2025

Standard Operating Procedure for BIMO Inspection Preparation and Response Strategy (FDA Specific)

SOP No.	CR/OPS/133/2025
Supersedes	NA
Page No.	1 of 72
Issue Date	26/08/2025
Effective Date	01/09/2025
Review Date	01/09/2026

Table of Contents

Purpose

The purpose of this SOP is to establish a standardized process for preparing for, managing, and responding

to FDA Bioresearch Monitoring (BIMO) inspections. These inspections ensure protection of human subjects, data integrity, and compliance with regulatory requirements under FDA oversight.

Scope

This SOP applies to sponsors, CROs, investigators, QA teams, and regulatory affairs personnel engaged in U.S. IND clinical trials subject to BIMO inspections. It includes pre-inspection readiness, inspection conduct, communication with inspectors, post-inspection follow-up, and CAPA management.

Responsibilities

Sponsor: Ensures inspection readiness across all sites and maintains oversight of documentation.
Investigator: Ensures site-level compliance, staff training, and availability of source records.
CRO: Provides support for inspection preparation, document retrieval, and site coordination.
Regulatory Affairs: Manages FDA communications and official responses.
QA: Conducts mock inspections, audits, and CAPA oversight.

Accountability

The Sponsor’s QA Director is accountable for FDA BIMO inspection readiness and remediation. Investigators are accountable for site-level preparation and subject protection during inspections.

Procedure

1. Pre-Inspection Preparation
1.1 Conduct mock inspections quarterly.
1.2 Verify TMF and ISF completeness and accuracy.
1.3 Train staff on inspection conduct.
1.4 Document in Pre-Inspection Readiness Log (Annexure-1).

2. Notification and Planning
2.1 Upon FDA notification, establish an inspection response team.
2.2 Inform site staff, CRO, and investigators.
2.3 Record in Inspection Notification Log (Annexure-2).

3. Conduct During Inspection
3.1 Ensure inspectors have access to requested documents promptly.
3.2 Maintain an Inspection Document Log (Annexure-3).
3.3 Record all inspector queries in an Inspector Query Log (Annexure-4).

4. FDA Form 483 Handling
4.1 Review Form 483 observations immediately.
4.2 Draft response within 15 business days.
4.3 Record in FDA 483 Response Log (Annexure-5).

5. CAPA Implementation
5.1 Develop CAPA plan for identified deficiencies.
5.2 Implement corrective measures at sponsor, CRO, and site levels.
5.3 Document in CAPA Log (Annexure-6).

6. Post-Inspection Follow-Up
6.1 Submit final remediation updates to FDA.
6.2 Archive inspection materials in TMF/ISF.
6.3 Record in Inspection Follow-Up Log (Annexure-7).

Abbreviations

SOP: Standard Operating Procedure
BIMO: Bioresearch Monitoring
FDA: Food and Drug Administration
IND: Investigational New Drug
CRO: Contract Research Organization
QA: Quality Assurance
TMF: Trial Master File
ISF: Investigator Site File
CAPA: Corrective and Preventive Action

Documents

Pre-Inspection Readiness Log (Annexure-1)
Inspection Notification Log (Annexure-2)
Inspection Document Log (Annexure-3)
Inspector Query Log (Annexure-4)
FDA 483 Response Log (Annexure-5)
CAPA Log (Annexure-6)
Inspection Follow-Up Log (Annexure-7)

References

Version: 1.0

Approval Section

Prepared By	Ravi Kumar, QA Specialist
Checked By	Sunita Reddy, Regulatory Affairs Officer
Approved By	Dr. Anil Sharma, Head Clinical Operations

Annexures

Annexure-1: Pre-Inspection Readiness Log

Date	Activity	Performed By	Status
01/09/2025	Mock Inspection	QA	Completed

Annexure-2: Inspection Notification Log

Date	FDA Office	Notification Type	Recorded By	Status
05/09/2025	CDER	Email Notification	Reg Affairs	Logged

Annexure-3: Inspection Document Log

Date	Document	Provided To	Recorded By	Status
07/09/2025	Protocol V1.0	FDA Inspector	RA	Submitted

Annexure-4: Inspector Query Log

Date	Query	Assigned To	Status
07/09/2025	Source Data Verification	Investigator	Answered

Annexure-5: FDA 483 Response Log

Date	Observation	Response Submitted	Reviewed By	Status
10/09/2025	Inadequate SAE Reporting	Yes	RA Head	Pending FDA Review

Annexure-6: CAPA Log

Date	Deficiency	CAPA	Responsible	Status
11/09/2025	SAE Reporting Gap	Revised SOP + Training	QA	Ongoing

Annexure-7: Inspection Follow-Up Log

Date	FDA Feedback	Action Taken	Responsible	Status
15/09/2025	CAPA Accepted	Filed in TMF	QA	Closed

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
26/08/2025	00	Initial version	New SOP creation	Head Clinical Operations

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