Project Description

We worked with our client to facilitate a class 1 recall of a specific product and to assist with the approval of a second product. We worked with engineers and quality professionals to execute effective CAPAs and addressed all known issues across the product family. We trained engineers and operations personnel on presenting data. We conducted 2 sitewide FDA readiness training courses. We assisted during the FDA inspections. The Class 1 recall was closed and the new product was approved shortly after the onsite inspection.