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