Pharmaceutical Warehouse Compliance Audit with Lot Tracking
Comprehensive compliance audit for pharmaceutical distributor ensuring FDA regulatory adherence, lot traceability, and expiration date management across temperature-controlled storage facilities.
Client Overview
A leading pharmaceutical distributor operating a 450,000 sq ft temperature-controlled warehouse facility serving hospitals, pharmacies, and healthcare providers across the southeastern United States.
The facility manages prescription medications, over-the-counter products, medical supplies, and controlled substances requiring strict FDA compliance, lot traceability, and expiration date management.
The Challenge
The distributor needed to verify inventory while ensuring full FDA compliance, lot traceability, and proper expiration date management across multiple temperature-controlled zones.
Regulatory Compliance
Strict FDA requirements for lot tracking, expiration date management, and controlled substance documentation with zero tolerance for errors.
Temperature Control
Multiple temperature zones requiring continuous monitoring and documentation during the audit process without compromising product integrity.
Lot Traceability
Complex lot tracking requirements with multiple lot numbers per SKU, requiring precise verification and documentation for regulatory compliance.
Operational Continuity
Critical need to maintain 24/7 operations serving healthcare providers while conducting comprehensive audit activities across all zones.
Our Solution
We deployed a specialized pharmaceutical audit team with FDA compliance expertise, utilizing advanced lot tracking technology and temperature monitoring protocols.
Compliance-First Approach
FDA-certified audit team following cGMP protocols with specialized training in pharmaceutical inventory management and regulatory requirements.
- DEA-compliant controlled substance verification
- FDA 21 CFR Part 11 documentation
- Chain of custody protocols
Advanced Lot Tracking
Proprietary scanning technology capturing lot numbers, expiration dates, and NDC codes with real-time validation against regulatory databases.
- Multi-lot SKU tracking
- Expiration date verification
- NDC validation
Temperature Integrity
Zone-based audit methodology with continuous temperature monitoring and minimal door-open time to maintain product integrity throughout the process.
- Real-time temperature logging
- Rapid zone completion
- Excursion documentation
Results & Impact
Successfully completed comprehensive compliance audit with full FDA regulatory adherence and detailed documentation for future inspections.
Complete lot tracking and verification across all pharmaceutical SKUs
Met all FDA regulations and DEA controlled substance requirements
Maintained 24/7 operations throughout the entire audit process
Comprehensive audit trail and variance analysis for regulatory review
"The team's expertise in pharmaceutical compliance was exceptional. They completed a thorough audit and helped us identify process improvements that strengthened our regulatory posture. Their lot tracking methodology and temperature monitoring protocols met FDA requirements. The detailed documentation they provided was invaluable during our recent FDA inspection."
Need Pharmaceutical Warehouse Compliance Expertise?
Our FDA-certified team specializes in pharmaceutical inventory audits with full regulatory compliance and lot traceability.
