The FDA, being what it is; has enormous power over the working of a medical device’s supply chain. It can virtually intercept a medical device at almost any stage through its various mechanisms such as recalls, injunctions, seizures and others. In its enthusiasm to ensure higher quality for medical devices, it has sometimes gone overboard to the extent that it is now a highly mistaken and feared regulatory body.
Making Supplier Audit Program comprehensible
Taking note of this perception, the FDA has been working hard to appear softer. One of the regulatory changes it has made to enforce this thinking has been to clearly state the conditions for meeting its expectations on Supplier Audit Program. The logic for choosing to make changes into the Supplier Audit Program is simple –as we just saw; it does not want to be seen as being arbitrary in selecting and punishing companies during their supply trail. It has set out a number of regulations and directions aimed at making the Supplier Audit Program simple and understandable.
Ask these questions to meet expectations
As a result, if companies have to meet the FDA’s expectations on Supplier Audit Program, they will need to ask themselves and answer questions such as: how do we address the FDA’s stated desire to require “on-site” audit of all Pharma suppliers? What expectations does the FDA have for meaningful, results-driven actions that address and resolve any underlying compliance issues or product problems? How do we reevaluate our vendors and the methods used in selecting, evaluating, auditing, retaining or cutting adrift such regulatory “partners” if we have to meet the new regulatory climate and be competitive?