recall-plan

name	recall-plan
title	Recall Plan and Procedure
description	Drafts FDA product recall plans compliant with 21 CFR Part 7, covering Recall Committee governance, health hazard evaluation, recall classification, notification protocols, effectiveness checks, product disposition, and termination procedures. Use when developing recall SOPs, updating recall procedures, drafting recall readiness plans, or preparing FDA-regulated product recall documentation.
author	CaseMark
author_url	https://github.com/CaseMark/skills/tree/main/skills/legal/recall-plan
license	Apache-2.0
version	0.1.0
execution_mode	open
jurisdiction	us
practice	regulatory
language	en

Recall Plan and Procedure

Drafts the company's official FDA-compliant recall protocol under 21 CFR Part 7 and the FD&C Act.

Prerequisites

Gather before drafting:

• Company profile — product categories, distribution channels, manufacturing sites
• Existing QMS documents — quality manual, CAPA procedures, complaint handling SOPs
• Regulatory filings — NDC numbers, device ID codes, 510(k)/PMA references
• Organizational chart — key personnel in QA, Regulatory, Legal, Operations, Communications, Executive
• Distribution records — channel structure, geographic scope, sub-distribution
• Prior recall history (if any) — FDA correspondence, lessons learned

Quick Start

1. Collect prerequisites and confirm product scope
2. Draft each section below in order
3. Flag evolving guidance with [VERIFY CURRENT GUIDANCE]
4. Route draft through Legal and Regulatory review

Core Sections

1. Purpose and Scope

State commitment to consumer safety, applicability to all FDA-regulated products, and governing authority (21 CFR Part 7, FD&C Act).

2. Recall Committee

Define these roles with named personnel:

Role	Typical Position	Key Duties
Chair	VP Quality+	Final recall decisions, FDA liaison oversight
Regulatory Lead	Head of RA	FDA notifications, classification coordination
Legal Counsel	GC / Outside Counsel	Risk assessment, notification review, litigation hold
Operations Lead	Head of Mfg/Supply Chain	Retrieval logistics, inventory quarantine
Communications Lead	Head of Corp Comms	Press releases, social media, consumer contact
Quality Lead	QA Director	HHE, effectiveness checks, CAPA

Convening: Within 4 hours (business) / 12 hours (after-hours). Maintain emergency contact tree with 2 backups per role and documented alternates.

Decisions: Consensus preferred; Chair has unilateral emergency authority. Document rationale, attendees, and dissenting views.

3. Health Hazard Evaluation (HHE)

Assess these factors in a formal report with supporting data: