Case Studies

Case Study: Supply Chain Overhaul Fixes 5-Year, $20M Issue

Overview

Having amassed more than $20M in fines from the US Food & Drug Administration in five years --most relating to a lack of control in its global supply chain process-- a large medical device company brought on Venetia Partners (VP) to develop a long-term solution.

Challenge

The company’s supply chain was inconsistent and lacked adequate documentation and shared procedures. Neither good nor poor quality could not be tracked through the global supply chain, which is the reason it took five years of fines to realize there was a reoccurring problem versus an isolated one.


Outcome

VP fully reviewed the process flow for devices identified in the FDA warnings as well as the technologies used to facilitate this supply chain. As a result of this in-depth evaluation, VP presented a comprehensive recommendation for a supply chain solution and technology options that seamlessly controlled documentation, accountability and material flow throughout the manufacturing process. The plan was implemented within the year and resulted in successfully passing subsequent FDA reviews.

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