casemark/recall-plan

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:

• 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