Temperature Mapping of Warehouse & Controlled Storage Units

Client Type

503B facility preparing for FDA inspection and licensure, with significant ambient and controlled temperature storage infrastructure

The Challenge

The facility stored bulk materials, finished products, and in-process intermediates in a combination of warehouse space, refrigerators, freezers, and incubators. The client needed to temperature map each zone and demonstrate that their storage conditions consistently met labeled requirements.

Our Solution

Restore Health Consulting performed:

  • Warehouse zone assessment to define mapping locations based on airflow, sun exposure, and loading patterns

  • Full 24–72 hour seasonal mapping of the warehouse and all TCUs (fridges, freezers, incubators)

  • Calibration review of all existing monitoring systems

  • Qualification reports including equipment specs, excursion analysis, and corrective actions (if needed)

The Outcome

✔ All zones were qualified and mapped with documented evidence of compliance
✔ Improved TCU alert settings and probe placement were implemented
✔ The facility passed its FDA inspection with no temperature control-related observations

“Restore helped us get ahead of what could have become a major inspection risk.”