lev-os 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