Recommended as a “consultative problem solver” Quantum was asked to provide initial consulting, testing, analysis and a regulatory data package for a major US sugar manufacturer whose product, thought to be contaminated by a nearby warehouse fire, had been quarantined by the FDA.
More than 4 million pounds of refined sugar was at stake.
The fire had started in an adjacent building, with smoke and fumes entering the sugar warehouse through the HVAC system. The sugar company tried on their own to get the FDA to lift the quarantine but resistance tightened as insufficient test data was submitted. Time was wasted when another CRO recommended testing for “volatile compounds” and “solvents” while the FDA rejected each submission citing “data not indicative of what a fire produces”.
Success was quickly achieved through Quantum’s knowledge of the chemistry of fire itself, along with a deeper understanding of what the FDA was actually looking for – specifically, polycyclic aromatic hydrocarbons (PAHs).
Proposing an analytical strategy and protocol, that was accepted by the FDA, Quantum fast-tracked the testing results and submitted a 150-page document in regulatory format to the FDA. The resulting evidence lifted the quarantine, allowing the sugar to safely go to market, saving the company millions.