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The QA Pharm

FDA Compliance

For Corrective Action Plans, Where Are the Resources?

What sells at the FDA

Published: Wednesday, May 18, 2011 - 05:30

Can you imagine the stream of firms that venture into their respective FDA district offices to give presentations on their warning letter response and to offer their assurance that they truly “get it?” You can be sure these firms had several dry runs and dress rehearsals to hone their material before stepping into what they perceive to be hostile territory. Their presentations were carefully crafted by the vice president, senior vice president, and executive vice president, and vetted by the lawyers. Consultants who claimed to have “been there and done that” were invited to the prep meetings to give their insight into what “sells” at the FDA.

When the meetings at the FDA are over, the firm’s representatives heave a sigh of relief and offer each other congratulations that it went well, because it “felt good.” It “felt good” because no one on the FDA side of the table objected or got upset. So they go back to their colleagues and claim victory. The story gets exaggerated and turns into something like, “They really liked our presentation.”

In my experience, the only thing that “sells” at the agency is results. The FDA “response” is a practiced, neutral expression that never is meant to signal agreement or acceptance. It’s all part of the, “We’ll see it for ourselves when we come back to reinspect” modus operandi.

However, we are starting to see an interesting twist at FDA that suggests it has finally figured out that there is more it can do to ensure effective action than sit through fancy presentations acting nonplussed while having smoke blown up its proverbial tailpipe.

The new twist is embedded in the Teva Warning Letter dated January 31, 2011, but only recently posted on the FDA website.

The theme of Teva’s Warning Letter is a problem of cross-contamination. Teva dutifully responded with a corrective action plan, which baited the usual response from the FDA—with a bit of a twist.

“We recognize that your October 7, 2010, response states that you are in the process of developing a risk management program for control of cross-contamination of the products produced at the Jerusalem Oral Solid Dosage (OSD) plant,” states the FDA. “However, you did not submit that plan, or data to support the effectiveness of the plan, with your response. We also recognize your commitment to finish the risk assessment within four months. Please provide us with any update on your timeline, and the identification of resources allocated to address this issue.”

It is not uncommon for the FDA to expect a plan and timeline in a response. In fact, companies frequently fail to provide a plan or timeline for completing corrective actions. However, in the case of Teva, FDA also requested the allocated resources to be identified.

That’s the twist, and that’s huge.

Frankly, this makes a lot of sense. The most successful corrective action plans have been those where the directly responsible individuals are named and appear in detailed project plans. There is a clear picture of what success looks like and how to get there. But most of all, the resources are identified to execute the work.

The regulation has always required sufficient numbers of qualified individuals to perform operations, so specifically asking about resource allocation to do the work is fair game.

Unusual, but fair.

In the past, the sincere delivery of a good presentation might have passed with the usual skepticism. Now be prepared to tell about the resources to pull it off.

Without the resources, it’s just another pretty presentation.


About The Author

The QA Pharm’s picture

The QA Pharm

The QA Pharm is a service of John Snyder & Co. Inc., provider of consulting services to FDA-regulated companies to build quality management systems and develop corrective actions that address regulatory compliance observations and communication strategies to protect against enforcement action. John E. Snyder worked at the lab bench, on the management board, and as an observer of the pharmaceutical industry for more than 30 years. His posts on The QA Pharm blog are straight talk about the challenges faced by company management and internal quality professionals. Synder is the author of Murder for Diversion (Jacob Blake Pharma Mystery Series Book 1).


It's Not Complicated.


In many ways I'm still a neophyte when it comes to the FDA & quality systems regulations. But, you don't need to be an expert to answer the basic questions regarding a project:

  1. What is the action item?
  2. Who is responsible for it?
  3. When will it be completed?

These three simple things provide a basic plan.

I've worked for three different medical device companies now. Without fail, meetings generate actions items (that are never documented) that aren't ever explicitly assigned to anyone or have an explicit completion date. The attitude is "we know what needs to be done and we'll do it." How such businesses function or even thrive escapes me.

I am glad that the FDA has taken to "trust but verify" approach -- data driven. Maybe this will prompt management to stop spending precious time developing mesmerizing presentations full of fluff and honing the "sell". Instead, they might try using that time to actually perform value added work.

Shrikant Kalegaonkar
twitter: shrikale