recall-plan

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.

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Repository: ThomasMoreAI/legal-skills-open
Letzte Quellaktivität: 27. Mai 2026 um 14:27
Erkannte Sprache von SKILL.md: Englisch
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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

Collect prerequisites and confirm product scope
Draft each section below in order
Flag evolving guidance with [VERIFY CURRENT GUIDANCE]
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:

Class	Standard	Examples
I	Reasonable probability of serious harm or death	Pathogen contamination, wrong active ingredient, life-threatening device failure
II	Temporary/reversible consequences; remote serious risk	Minor contamination, labeling errors, device defects causing temporary harm
III	Not likely to cause adverse consequences	Minor labeling violations, aesthetic defects

Level	Scope	When
Consumer/User	End users; public warnings	Serious hazard + product reached consumers
Retail	Retailers/dispensers only	Hazard manageable at retail; product distinguishable
Wholesale	Wholesale chain only	Product not yet at retail

Level	Typical Class	Requirement
A	I	Contact 100% of direct accounts
B	II	Contact representative sample
C	III	Confirm notification receipt

Option	When	Requirements
Destruction	Contamination, fundamental defects (default)	Witnessed, certificate (date/method/qty/lots), photo/video for high-value
Reconditioning	Correctable defect; FDA pre-approval	Detailed proposal, QC verification per unit, batch records
Relabeling	Labeling-only; FDA pre-approval	Proposal, per-unit verification, records
Return to mfg	Evaluation/rework	Full chain of custody

recall-plan

Installationsoptionen

Quelldateien prüfen

Recall Plan and Procedure

Prerequisites

Quick Start

Core Sections

1. Purpose and Scope

2. Recall Committee

3. Health Hazard Evaluation (HHE)

Recall Plan and Procedure

Prerequisites

Quick Start

Core Sections

1. Purpose and Scope

2. Recall Committee

3. Health Hazard Evaluation (HHE)

4. Recall Strategy

5. Notification Protocols

FDA Notification (21 CFR 7.46)

Trade Notifications

Public/Consumer Notifications

6. Effectiveness Checks

7. Product Disposition

8. Recall Termination

9. Post-Recall Review

Pitfalls

recall-plan

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Installationsoptionen

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Mehr aus diesem Repository

Mehr aus diesem Repository

Recall Plan and Procedure

Prerequisites

Quick Start

Core Sections

1. Purpose and Scope

2. Recall Committee

3. Health Hazard Evaluation (HHE)

Recall Plan and Procedure

Prerequisites

Quick Start

Core Sections

1. Purpose and Scope

2. Recall Committee

3. Health Hazard Evaluation (HHE)

4. Recall Strategy

5. Notification Protocols

FDA Notification (21 CFR 7.46)

Trade Notifications

Public/Consumer Notifications

6. Effectiveness Checks

7. Product Disposition

8. Recall Termination

9. Post-Recall Review

Pitfalls