FDA Storage & Handling
Set up physical storage and handling for FDA-regulated medical devices: environmental controls, segregation, and audit-ready records.
Overview
Physical storage is the unglamorous regulatory layer most teams underbuild. The first FDA inspection of a warehouse with sloppy segregation, missing temperature logs, or inadequate quarantine procedures becomes a Form 483.
We design the storage operation: racks, temperature and humidity controls, segregation policies, quarantine workflows, and the records that demonstrate ongoing compliance.
Our Process
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1
Storage requirements analysis
Device-class-specific environmental and segregation requirements.
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2
Site assessment
Existing facility evaluated against requirements.
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3
Design & remediation
Layout, equipment, monitoring systems.
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4
SOPs & training
Operating procedures, training records, refresh cadence.
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5
Ongoing audit posture
Mock inspections, record reviews, corrective action loops.
Frequently Asked Questions
Cold-chain handling?
Yes, refrigeration and excursion handling fully covered.
Distributor warehouse coverage?
We extend the same discipline to distributor partners under your QMS umbrella.
What about controlled substances?
Coordinated with DEA controls where applicable.
Can this work for 3PL relationships?
Yes, most warehouses are 3PL. Quality agreements extend the controls.
Be ready for the warehouse inspection.
Tell us your device storage footprint. We will return a readiness assessment within four weeks.
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