Comment by simonster

Per https://www.fda.gov/inspections-compliance-enforcement-and-c..., it looks like the FDA is unhappy that Cue did something to identify whether the cartridge went outside of the allowed temperature parameters in transit (CP-4166 says that the seller is responsible if a device malfunctions due to damage in transit) and didn’t test each lot as much as they were supposed to or maybe used a lower accuracy threshold than stated in their claims.