Field Alert Report
Uploaded by
Vinay PatelField Alert Report
Uploaded by
Vinay PatelField Alert Report (FAR)
1. Introduction
This Field Alert Report (FAR) is prepared and submitted to the U.S. Food and Drug
Administration (FDA) in accordance with 21 CFR 314.81(b)(1). The purpose of the FAR is to
promptly notify the FDA about any information concerning product quality defects, safety
issues, or labeling discrepancies that may impact patient safety or product efficacy.
2. Purpose
The purpose of this report is to provide immediate notification to FDA about confirmed or
suspected issues in distributed drug products and to outline the findings, root cause (if
available), and actions taken.
3. Scope
This FAR applies to all marketed drug products manufactured, packaged, or distributed by
the company that are subject to FDA reporting requirements.
4. Product Information
• Product Name: __________________________
• Dosage Form: __________________________
• Strength: __________________________
• NDC Number: __________________________
• Batch/Lot Number(s): __________________________
• Expiry Date: __________________________
5. Description of the Problem
Provide a detailed description of the issue that triggered the FAR, including:
• Nature of defect (e.g., contamination, incorrect labeling, out-of-specification results)
• Date the problem was first discovered
• How the issue was detected (e.g., complaint, internal testing, inspection)
• Impacted quantities and distribution regions
6. Initial Investigation
Summarize any preliminary investigation results available at the time of reporting:
• Steps taken to confirm the issue
• Tests conducted and their results
• Immediate containment actions
7. Root Cause Analysis (if known)
If the root cause is known at the time of reporting, provide details. If unknown, indicate that
the investigation is ongoing and that updates will be provided to FDA.
8. Corrective and Preventive Actions
List the actions taken or planned to address the issue, such as:
• Product recall or withdrawal
• Process changes
• Additional employee training
• Supplier qualification improvements
9. Reporting Timelines
The FAR must be submitted to the FDA within three (3) working days of receiving the
information, as required by 21 CFR 314.81(b)(1).
10. Contact Information
Name: __________________________
Title: __________________________
Department: __________________________
Phone: __________________________
Email: __________________________
