casemark/recall-plan
skills/legal/recall-plan/SKILL.md
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.
$ install --global
skillsauthnpx skillsauth add casemark/skills recall-planInstall this skill globally with one command. Works with Claude Code, Cursor, and Windsurf.
Security Scan Results
3 of 9 scanners reported clean
Some scanners were skipped, did not run, or reported a non-clean status. Review each row below.
3
Scanners Passed
9
Scanners in report
Clean
TrivyContainer and dependency vulnerability scanner
95%
Clean
SemgrepStatic code analysis for vulnerabilities
95%
Clean
mcp-scan (Snyk)Model Context Protocol security validation
95%
Skipped
Snyk (dep)Open source security scanning
50%
Skipped
Socket.devSupply chain security analysis
50%
Skipped
VirusTotalMulti-engine malware detection
50%
Skipped
CrowdStrikeAdvanced threat intelligence
50%
Skipped
OSV-ScannerOpen Source Vulnerability database check
50%
Skipped
OWASP Dep-Check
50%
Last scanned: Apr 17, 2026, 2:17 PM17.4s1 file scanned
SKILL.md
- name:
- recall-plan
- 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.
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:
- Nature of defect (contamination, mislabeling, malfunction)
- Adverse outcome likelihood (scientific/medical evidence)
- Vulnerable populations (pediatric, immunocompromised, elderly)
- Severity x probability of harm
- Defect prevalence in distributed product
FDA recall classification:
| 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 |
Company proposes classification; FDA assigns final. Complete HHE proportionate to urgency.
4. Recall Strategy
Depth of recall:
| 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 |
Public warning required when: Class I + product reached consumers, product not easily distinguished from safe product, or FDA requests it.
Document: Depth justification, public warning plan, timeline, FDA consultation record, adjustment provisions.
5. Notification Protocols
FDA Notification (21 CFR 7.46)
Submit to jurisdictional FDA district office immediately upon initiating recall; no later than 10 working days.
- [ ] Product identity (NDC/device ID, lot numbers)
- [ ] Reason for recall — specific defect
- [ ] HHE and proposed classification
- [ ] Quantity produced and time span
- [ ] Quantity in distribution
- [ ] Distribution pattern (geography, customer types)
- [ ] Proposed strategy (depth, warnings, effectiveness level)
Trade Notifications
Legal + Regulatory must approve before distribution.
- [ ] Prominent "RECALL NOTICE" header
- [ ] Product ID with lot numbers and visual aids
- [ ] Plain-language recall reason
- [ ] Instructions for identifying affected inventory
- [ ] Required actions (quarantine, return, destroy)
- [ ] Lot verification procedure
- [ ] Contact information
- [ ] Request for written confirmation
Public/Consumer Notifications
Coordinate press releases with FDA. Use social media for rapid dissemination. Contact consumers directly when registry data available.
Record all notifications: date/time, recipients, method, copies, responses.
6. Effectiveness Checks
| Level | Typical Class | Requirement | |-------|--------------|-------------| | A | I | Contact 100% of direct accounts | | B | II | Contact representative sample | | C | III | Confirm notification receipt |
Collect per check: notification receipt confirmation, product identified, quarantine confirmed, quantity reconciliation, sub-distribution info.
Report to FDA: At 2-week, 4-week, and 8-week intervals (or as directed).
Non-responsive escalation: Repeated contact → certified mail with return receipt → personal visit → notify FDA.
7. Product Disposition
| 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 |
Storage: Segregated, restricted access, conspicuously marked, full inventory controls.
Accountability: Periodic reconciliation of distributed vs. returned vs. disposed quantities. Investigate discrepancies. Prevent unauthorized re-entry into distribution.
8. Recall Termination
FDA decides termination, not the company. Never unilaterally declare completion or make public statements suggesting recall has concluded without written FDA agreement.
- [ ] Final effectiveness check results (% accounted for)
- [ ] Quantity reconciliation with explanations for gaps
- [ ] Complete disposition records
- [ ] All recall notifications/communications
- [ ] Outcome summary with lessons learned
- [ ] Formal termination request
9. Post-Recall Review
Monitoring: Handle recalled product surfacing after termination; notify FDA if significant quantities found.
Retention: Complete recall file minimum 2 years beyond termination (longer per litigation holds).
Review checklist:
- [ ] Timeliness of initial HHE
- [ ] Adequacy of recall strategy and mid-course adjustments
- [ ] Effectiveness of notifications
- [ ] Efficiency of recovery and disposition
- [ ] Resource and personnel adequacy
- [ ] Plan gaps identified
- [ ] Root cause / systemic quality issues
Produce written report with CAPA recommendations tracked through QMS.
Pitfalls
- Never self-terminate: Only FDA can authorize recall completion
- Classification is FDA's call: Company proposes; FDA assigns final classification
- Reconditioning/relabeling require pre-approval: Do not proceed without FDA authorization
- Guidance evolves: Flag sections with
[VERIFY CURRENT GUIDANCE]where FDA guidance may have changed - Cross-reference requirements: Medical devices — MDR reporting (21 CFR Part 803)
[VERIFY]; Drugs/biologics — field alert reporting (21 CFR 314.81)[VERIFY] - International distribution: Coordinate with foreign regulatory authorities if distributing outside the US
- Dual audience: Maintain legal precision for counsel while keeping operational sections accessible to non-legal staff
Related Skills
casemark/medical-records-gap-analysis
tools
VerifiedTrustedCommunity
Audits the complete in-scope medical-record universe in a litigation matter and produces an attorney-facing, Bates-cited analysis of treatment gaps, missing records or providers, baseline coverage, material billing or production mismatches, and complaint evolution. Use when asked to find missing medical records, analyze treatment gaps or first-care timing, identify absent providers, assess whether a production is complete, or prepare a records-request target list. Use medical-record-chronology instead when the primary request is a chronological clinical narrative.
40SKILL.mdUpdated Sep 3, 2026
casemark/private-placement-memo
development
VerifiedTrustedCommunity
Drafts a legally compliant Private Placement Memorandum for Regulation D offerings (Rule 506(b)/506(c)), covering full disclosure framework including risk factors, capitalization, securities terms, use of proceeds, and investor qualification requirements. Enforces SEC anti-fraud compliance under Section 10(b)/Rule 10b-5, blue sky law considerations, and accredited investor verification under Rule 501. Use this skill when drafting PPMs, offering memorandums, Reg D disclosure documents, or private offering circulars for issuers raising capital from sophisticated investors. Also trigger when the user mentions private placement disclosure, offering memorandum, Reg D fundraising, or accredited investor verification. Even if the user just says "PPM" or "draft our offering memo," use this skill.
40SKILL.mdUpdated Apr 17, 2026
casemark/privacy-law-updates
data-ai
VerifiedTrustedCommunity
Generates structured privacy and data protection law briefings across US, EU, UK, and other jurisdictions. Organizes by jurisdiction with compliance deadlines, enforcement actions, and legislative changes. Use when preparing privacy law briefings, compliance updates, regulatory change summaries, or data protection landscape reviews.
40SKILL.mdUpdated Apr 17, 2026
casemark/prior-art-summary
testing
VerifiedTrustedCommunity
Generates structured summaries of prior art references for patent prosecution, validity analysis, and freedom-to-operate assessments. Maps disclosures to claim elements with precise citations. Use when summarizing prior art, analyzing patent landscapes, mapping references to claims, or preparing office action responses.
40SKILL.mdUpdated Apr 17, 2026