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.

Aller à l'installation

Dépôt: ThomasMoreAI/legal-skills-open
Dernière activité de la source: 27 mai 2026 à 14:27
Langue détectée de SKILL.md: anglais
Étoiles: 40
Forks: 4

Options d'installation

Le prompt qui vérifie d'abord la source est sélectionné par défaut. Vous pouvez passer à une commande directe ou télécharger une copie locale.

Installer avec Codex ou Claude Copiez ce prompt, collez-le dans Codex, Claude ou un autre assistant, puis laissez-le vérifier la page du skill et l'installer pour vous.

Une commande directe contourne le prompt de vérification. Examinez la source avant de l'exécuter.

npx skills add https://github.com/ThomasMoreAI/legal-skills-open --skill recall-plan

La commande reste sur une seule ligne. Faites défiler horizontalement pour la vérifier avant de la copier.

Vous préférez une copie locale ? Téléchargez les fichiers actuellement disponibles dans SkillsMP.

Vérifiez les fichiers source

Lisez SKILL.md et les fichiers associés affichés par SkillsMP avant de décider de l'installer.

SKILL.md

Instructions source · Aperçu en lecture seule

Retour à la recherche Retour à l’installation

fetching-arbitration-rules

Use when retrieving arbitration institutional rules (ICC, LCIA, SCC, SIAC, HKIAC, VIAC, МКАС/МАК при ТПП України, UNCITRAL) — fetching current version, verifying redaction applicable to the date of arbitration agreement, constructing URLs for official rule texts

2026-06-12

determining-pl-request-regime

Use when choosing the Polish legal regime for letters, requests, applications, complaints, petitions, public-information requests, KPA filings, PPSA complaints, RODO access requests, registry extracts, court-file access, tax/ZUS/cudzoziemcy/USC procedures, or professional lawyer letters. Prevents mixing UDIP, KPA, PPSA, RODO, registry, special-procedure, and advocate/radca letter regimes.

2026-06-12

applying-new-york-convention

Use when preparing applications for recognition and enforcement of foreign arbitral awards in Poland, applications for setting aside arbitral awards under KPC art. 1205–1211, or opposing such applications — mapping Article V of the 1958 New York Convention to art. 1214–1215 of the Polish KPC, identifying grounds for refusal, structuring public policy arguments

2026-06-12

Tout voir dans ce dépôt

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

Options d'installation

Vérifiez les fichiers source

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

Informations de source

Options d'installation

Vérifiez les fichiers source

Plus depuis ce dépôt

Plus depuis ce dépôt

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