The recent actions taken by the FDA against a well known corporation illustrates the danger of having a quality system that is not in compliance with current FDA expectations for the company’s current business activities.
It is worth noting that under Section 518 of the Federal Food, Drug, and Cosmetic Act, the FDA has authority to order the repair, replacement or refunds of faulty and fraudulent products.
This Act also allows consumers to seek economic redress if they have been sold when they have been sold defective medical devices that present unreasonable risk.
With the FDA’s tougher stance on enforcement and product safety standards, failure to take a critical, honest view of their compliance with FDA quality control standards can result in devastating losses for the companies concerned.
Only by proactively addressing issues early and ensuring early expert intervention is at hand can businesses be assured that they will not fall foul of the FDA.
How can a firm be prepared as it relates to the FDA current enforcement policies? First of all, understanding the FDA's new stricter enforcement policies, as well as how the FDA will enforce them, is the first step.
Fill out the form on the left to ensure that your Quality Policies are in alignment with the sections of the Code of Federal Regulations (CFR) that are applicable to your firm's line of business.