Avoiding punitive actions from the FDA

[Adam Fleming]

Although the news of a company receiving strictures from the FDA in the form of 483s, Warning Letters, and even Consent Decrees is a near daily occurrence in the industry; when it happens, it takes such companies by surprise. Not only is the company’s executive management caught off guard by these events; they are also embarrassed by the bad press they get, as well by the very expensive and damaging investigations and corrective and preventive action that follow.

The problems do not end there. When a company gets hauled up by the FDA for Quality and Compliance issues, they can have all the core elements of their business seriously dented: Customer satisfaction and safety, sales, market share, and business results. Worst of all, many companies’ managements can face personal civil or criminal charges for failure to address issues.

Reasons for failure to comply with FDA expectations

Although any company getting hauled up by the FDA is theoretically and technically possible, why do managements get baffled when they get a 483, Warning Letter, or Consent Decree? These are some of the reasons:

a)    Most companies do not get the right data or information with which to identify Quality and Compliance issues. It is observed that in most companies the invite FDA actions, the data had not clearly directed the company to a need or sense of urgency for improvement

b)    In instances where they did get the right information, they failed to effectively prioritize, resource, and implement corrective actions

c)     They did have the information, but the company’s culture prevented them from creating an appropriate environment for identifying, escalating, and mitigating Quality and Compliance issues.

The way out

To help overcome all these issues associated with actions that lead to FDA actions; the real solution lies in implementing a well-designed Quality Management System and program of compliance. This is the only antidote to everything that retards an improvement in product quality, customer satisfaction, and business success.

All these point to the central fact that a company in which the management lacks awareness for creating effective methods to identify, mitigate, and measure compliance, and the risks that cause them within their Quality System is most susceptible to FDA actions. The root to avoiding such punitive actions from the FDA thus is for management to close the gaps in the Quality System and the risk that such a company’s products pose for its customers.

Learn the ways of getting the QMS right

A webinar that is being organized by Compliance4All, a very well-known provider of professional trainings for all the areas of regulatory compliance, will offer a thorough understanding of how to overcome issues that lead to FDA actions.

The speaker at this webinar is Susanne Manz, an accomplished leader in the medical device industry who emphasizes quality, compliance and Six Sigma, and brings extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities.

Visit http://www.compliance4all.com/control/w_product/~product_id=501038L... to enroll for this webinar.

At this webinar, Susanne will highlight red-flags and identify ways to reduce compliance and quality risk, which will help a company use quality and compliance as a competitive strength.