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Recall Plan

Draft FDA Recall Plans in Minutes, Not Hours

12 minutes with CaseMark

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12 minutes with CaseMark

What you'll need

  • Company Profile
  • Quality Management System Documents
  • Organizational Chart

SOC 2 Type II · HIPAA compliant · $5 free credit

Workflow

Overview

CaseMark's Recall Plan skill automates the drafting of comprehensive FDA-compliant product recall procedures under 21 CFR Part 7 and the FD&C Act. It generates complete recall documentation covering committee governance, health hazard evaluation, classification, notification protocols, effectiveness checks, product disposition, and termination procedures. The result is a production-ready recall plan that would traditionally take weeks to draft manually.

Drafting FDA-compliant recall plans is a complex, time-intensive process that requires deep regulatory knowledge across health hazard evaluation, recall classification, notification protocols, and effectiveness checks. Quality and regulatory teams often spend weeks assembling these documents, coordinating across legal, operations, and communications stakeholders, and ensuring every section meets 21 CFR Part 7 requirements.

CaseMark automates the heavy lifting of recall plan drafting by analyzing your company profile, QMS documents, and organizational structure to generate a comprehensive, regulation-aligned recall procedure. The AI produces a complete, multi-section plan ready for legal and regulatory review, transforming a weeks-long process into a streamlined workflow that ensures nothing is missed.

How it works

  1. 1. Upload your company profile, QMS documents, and organizational chart

  2. 2. AI analyzes your inputs and drafts a comprehensive recall plan under 21 CFR Part 7

  3. 3. Review the generated plan, customize roles, timelines, and notification protocols

  4. 4. Export the finalized recall plan in your preferred format (DOCX, PDF)

What you get

  • Purpose and Scope Statement

  • Recall Committee Governance Structure

  • Health Hazard Evaluation Framework

  • Recall Classification Procedures

  • FDA Notification Protocols

  • Distribution and Retrieval Logistics

  • Effectiveness Check Procedures

  • Product Disposition and Quarantine Protocols

  • Communications Plan

  • Recall Termination Procedures

What it handles

  • Recall Committee governance structure with roles, duties, and convening protocols

  • Health hazard evaluation framework aligned with FDA classification criteria

  • Notification protocol drafting for FDA, distributors, and consumers

  • Effectiveness check procedures with audit-ready documentation

  • Product disposition and quarantine workflow generation

  • Recall termination procedures with FDA correspondence templates

Required documents

  • Company Profile

    Company overview including product categories, distribution channels, manufacturing sites, and regulatory filing references (NDC numbers, device IDs, 510(k)/PMA references)

    .pdf, .docx

  • Quality Management System Documents

    Existing quality manual, CAPA procedures, complaint handling SOPs, and any current recall-related documentation

    .pdf, .docx

  • Organizational Chart

    Key personnel across QA, Regulatory, Legal, Operations, Communications, and Executive functions with contact information

    .pdf, .docx, .xlsx

Supporting documents

  • Distribution Records

    Channel structure, geographic scope, and sub-distribution network details

    .pdf, .docx, .xlsx

  • Prior Recall History

    Previous FDA correspondence, recall reports, and lessons learned from prior recall events

    .pdf, .docx

  • Regulatory Filings

    NDC numbers, device identification codes, 510(k) or PMA references, and other regulatory submission details

    .pdf, .docx

Why teams use it

Reduce recall plan drafting time from weeks to minutes with AI-powered document generation

Ensure regulatory alignment with 21 CFR Part 7 structure, terminology, and procedural requirements

Standardize recall readiness across product lines, facilities, and distribution channels

Strengthen FDA audit preparedness with comprehensive, well-documented recall procedures

Questions

Does this recall plan comply with current FDA regulations?

CaseMark generates recall plans structured around 21 CFR Part 7 and the FD&C Act, covering all required elements including health hazard evaluation, recall classification, and effectiveness checks. The output flags areas where evolving guidance should be verified, and we recommend routing the final draft through your Legal and Regulatory teams.

What types of FDA-regulated products does this cover?

CaseMark's recall plan skill is designed for all FDA-regulated product categories, including pharmaceuticals, medical devices, biologics, food, and cosmetics. The generated plan adapts its scope and notification protocols based on the product information you provide.

Can I customize the Recall Committee roles and responsibilities?

Absolutely. CaseMark generates a default governance structure based on FDA best practices, but every role, duty assignment, convening timeline, and escalation protocol can be fully customized to match your organization's structure and personnel.

How long does it take to generate a complete recall plan?

CaseMark typically generates a comprehensive, multi-section recall plan in approximately 10-12 minutes. This replaces what traditionally takes days or weeks of manual drafting, giving your team a production-ready starting point for legal and regulatory review.

Does the output include effectiveness check procedures?

Yes. CaseMark drafts detailed effectiveness check procedures including audit levels, sampling methodologies, and documentation requirements aligned with FDA expectations. These help demonstrate to the FDA that your recall is achieving its intended purpose.

Can I use this to update an existing recall SOP?

Yes. Upload your existing recall procedures as part of your QMS documents, and CaseMark will generate an updated plan that incorporates your current framework while ensuring alignment with 21 CFR Part 7 requirements and current best practices.

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