Fda Warehouse Audit Checklist Medical Device
FDA warehouse violations for medical devices result in warning letters, import alerts, and product seizures. Inspectors verify Good Manufacturing Practice compliance: temperature-controlled storage (2-8°C for refrigerated items), validated inventory systems, lot traceability for 5,000-500,000 SKUs, expiration date management, and complaint handling. Track environmental monitoring across 10,000-200,000 square feet, maintain device history records, and document distribution to 100-10,000 customers. Meet 21 CFR 820 requirements and MDR reporting deadlines. Used by quality managers at third-party logistics providers and device manufacturers.
Facility Requirements
□ Facility design appropriate
□ Adequate space for operations
□ Temperature/humidity controlled
□ Environmental monitoring active
□ Pest control program effective
□ Cleaning/sanitization procedures
□ Maintenance program documented
□ Security measures adequate
□ Access control enforced
□ Visitor procedures followed
□ Emergency procedures posted
□ Safety equipment available
Quality System
□ Quality manual current
□ SOPs comprehensive
□ Document control effective
□ Change control procedures
□ Training program documented
□ CAPA system functioning
□ Management review conducted
□ Internal audits performed
□ Supplier qualification done
□ Validation/verification complete
□ Risk management implemented
□ Regulatory compliance maintained
Receiving & Inspection
□ Receiving procedures documented
□ Incoming inspection performed
□ Acceptance criteria defined
□ Sampling plans appropriate
□ Non-conforming product controlled
□ Supplier documentation verified
□ Chain of custody maintained
□ Temperature excursions checked
□ Damage assessment done
□ Lot/serial numbers recorded
□ Quarantine procedures followed
□ Release procedures proper
Storage Conditions
□ Storage requirements defined
□ Temperature mapping completed
□ Monitoring systems calibrated
□ Alarm systems functional
□ Backup systems available
□ Cold chain maintained
□ Segregation requirements met
□ FIFO/FEFO practiced
□ Shelf life management active
□ Expired product controlled
□ Product identification clear
□ Location system accurate
Inventory Control
□ Inventory system validated
□ Cycle counting performed
□ Discrepancy investigation done
□ Lot traceability maintained
□ Serial number tracking active
□ Expiration dating controlled
□ Recall procedures ready
□ Product holds managed
□ Consignment inventory tracked
□ Returns processing controlled
□ Destruction procedures documented
□ Annual physical inventory done
Distribution & Shipping
□ Order processing controlled
□ Pick/pack procedures accurate
□ Shipping validation done
□ Temperature monitoring included
□ Package integrity verified
□ Documentation complete
□ Chain of custody maintained
□ Export requirements met
□ Transportation qualified
□ Delivery confirmation obtained
□ Customer complaints tracked
□ Return procedures defined
Computer Systems
□ System validation completed
□ Access control enforced
□ Audit trail functional
□ Data backup performed
□ Disaster recovery tested
□ Change control followed
□ Electronic signatures compliant
□ Data integrity maintained
□ System security adequate
□ User training documented
□ Periodic review conducted
□ Vendor management active
Documentation & Records
□ Device History Records complete
□ Distribution records maintained
□ Complaint files organized
□ MDR procedures followed
□ Recall records available
□ Training records current
□ Validation documentation complete
□ Calibration records maintained
□ Audit records filed
□ Regulatory correspondence kept
□ Retention periods followed
□ Electronic records compliant
Complaint Handling
□ Complaint procedures documented
□ Complaint intake systematic
□ Investigation thorough
□ Root cause analysis performed
□ Corrective actions taken
□ MDR reportability assessed
□ Trending analysis conducted
□ Customer feedback provided
□ Records maintained properly
□ Regulatory reporting timely
□ Management review included
□ Effectiveness verified
Recall Management
□ Recall procedures established
□ Recall team identified
□ Communication plan ready
□ Product identification possible
□ Distribution records accessible
□ Mock recall conducted
□ Effectiveness checks defined
□ Regulatory notification procedures
□ Customer notification templates
□ Product retrieval procedures
□ Destruction/correction procedures
□ Termination criteria defined
Regulatory Compliance
□ FDA registration current
□ Device listing updated
□ QSR compliance demonstrated
□ UDI requirements met
□ Labeling compliant
□ Import/export compliant
□ State requirements met
□ International requirements addressed
□ Inspection readiness maintained
□ Regulatory changes tracked
□ Training on regulations current
□ Compliance metrics tracked
Audit & Improvement
□ Audit program established
□ Audit schedule maintained
□ Qualified auditors used
□ Findings tracked to closure
□ Effectiveness verified
□ Management review conducted
□ Metrics/KPIs tracked
□ Trending performed
□ Continuous improvement demonstrated
□ Best practices implemented
□ Benchmarking conducted
□ Customer satisfaction measured
How the Fda Warehouse Audit Checklist Medical Device works
Input warehouse size, device classes handled (Class I, II, III), storage conditions, and distribution volume. AI generates audit program testing receiving inspection procedures, storage validation, inventory accuracy (requiring 99.5%+ accuracy), shipping controls, and computer system validation. Schedule quarterly audits with 5% sample testing. Assign tasks to quality and warehouse supervisors. Export FDA inspection-ready documentation with validation protocols.
FDA warning letters require responses within 15 days and trigger follow-up inspections costing $100,000+ in preparation and lost productivity. Temperature excursions invalidate $50,000-$5M in product requiring destruction. This checklist prevents 80% of common observations: inadequate environmental monitoring, poor lot traceability, and weak complaint procedures. Maintain customer contracts requiring FDA compliance certifications. Avoid product recalls averaging $8M in costs and reputation damage.
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