Becton Dickinson & Company – FDA Warning Letter, Jul 6, 2017

On May 15, 2017, the FDA inspected Becton Dickinson and Company in Franklin Lakes, New Jersey, and found that the BD Vacutainer Blood Collection tubes, including BD Vacutainer plastic tubes with K2EDTA anticoagulant, were adulterated and misbranded.

The BD Vacutainer K2EDTA Tubes were adulterated because the company did not have an approved application for premarket approval (PMA) or an approved application for an investigational device exemption. They were also misbranded because the company did not notify the FDA of its intent to introduce the devices into commercial distribution after making significant changes to the rubber stoppers' formulation, which could affect the devices' safety or effectiveness. The company's testing to evaluate the change was inadequate.

The inspection also revealed that the BD Vacutainer K2EDTA Tubes were adulterated because their manufacturing, packing, storage, or installation methods, facilities, or controls did not conform to the Quality System regulation (21 CFR Part 820).

Specific violations included: 1. **Design validation failures (21 CFR 820.30(g)):** Inadequate clinical testing for design changes, reliance on insufficient in-house testing, and failure to document the impact of process validation failures on stopper performance. 2. **Inadequate documentation of design input requirements (21 CFR 820.30(c)):** Failure to