Business Challenge: The client had been issued a 483 with findings from their FDA inspection requiring immediate response and remediation.

Proposed Solution: We sent our QA/RA expert out to spearhead the FDA response project. After thoroughly reviewing the FDA findings, our project leader coordinated with client personnel to form a response team and formulate the response with a corresponding corrective action plan.

Results/Value Delivered: The client agreed with all proposed activities including a product recall. The results are ongoing. However, the outcome from this project is that the client asked Neozene to return and give them a full audit of their entire Quality Management System and preparation for the ISO 13485 2016 release.