Warning Letter or No Warning Letter?
            That is the question

Soon the public may be singing, "Oh where, oh where did our FDA go, oh where, oh where did they go?" as the FDA goes gently into that dark, dark night.

This new Warning Letter Initiative of the FDA -  supposedly set to go into effect sometime later this year and run for 18 months - will allow medical device companies to preempt the issuance of a warning letter. Of course this would involve several conditions, one of them being that the company promises corrective actions.

Someone call an ambulance! The FDA is bleeding to death. All it’s strength is being sucked out, like superman in a room full of Kryptonite. What is truly interesting food for thought, is the question of what the FDA will give up next.

Why would the FDA agree to reduce the number of warning letters it issues?

It would appear that warning letters are the only regulatory process remaining for the FDA to get the industry to comply with the regulations. This becomes especially true if you look at the number of prosecutions and injunctions the FDA processed in the last few years.

This warning letter initiative appears to be a continuance of the medical device initiative.  This pilot program is a result of recent FDA/medical device industry grassroots forums where the industry wanted to know why warning letters have to be issued if corrective actions are either taken before the inspection is completed or promises were made to bring the problems into compliance.

The warning letter initiative will work like this:

First, only certain companies will be allowed to participate in this program.

The program should work in the manner described below :

Following a domestic device quality system inspection, which finds CGMP deficiencies that warrant a warning letter, the company is to be given 15 working days to respond from the issuance date of the FDA483. If the firm’s written response to the FDA483 is deemed to be satisfactory by the district office, then the warning letter should not be issued.

If the district is essentially satisfied with the written response to the FDA483 but needs further classification, it may seek additional information via untitled correspondence, meetings or telephone.

Now, if the firm fails to respond to the FDA483, a warning letter should be sent to the firm once the 15 working day period has expired.(HINT: make sure that your response is sent return receipt requested.) If the district receives a response to the FDA483 within 15 days, the district has 15 days from the receipt date to determine whether the response is satisfactory.  If it is necessary for the district to consult with other FDA offices there will be an additional 15 to 30 days for the district to respond.

If the firm’s written response to the FDA483 is determined to be unsatisfactory, the district would send a warning letter to the establishment.

When no warning letter is issued as a result of this process, the district will mail a post-inspectional notification letter, which is in fact a non-warning letter, letter to the firm. This basic letter would include the following:

At the end of the inspection, the FDA investigator left a list of inspectional observations at your firm. We have received your firm’s written response, dated to the FDA483. Copies of this response and the FDA483 are enclosed.

While this inspection found deficiencies of your quality system that would warrant a warning letter if not corrected, your written response has satisfied us that you either have taken or are taking appropriate corrective actions. At this time, the FDA does intend to take further action based on these inspectional findings. The agency is relying on your commitment regarding corrective actions and, should we later observe that the deviations form the quality system regulation have not been remedied, future regulatory action (e.g., seizure, injunction and civil penalties) may be take without further notice.

The question now becomes, is a letter that is not titled "Warning Letter" a warning letter or not?

So basically, this would be a warning letter without the warning letter title written at the top of the letter. The reasons that this is beneficial to the industry is that this letter will not be posted like the warning letters are presently being posted, letting customers and competitors know what CGMP problems had been found at the company.

Here comes the hitch. The FDA is not letting the company of the hook completely. You must be aware, that when the no "warning letter" letter is issued, as described previously, and the next inspection discloses CGMP deficiencies, then the FDA personnel have been instructed to proceed as if a warning letter had been issued for the previous inspection. They are instructed to consider the appropriate enforcement action as if the inspection was a follow up to a warning letter inspection.

This program will run for a period of 18 months and then be evaluated.

So, the FDA is again making the process of dealing with the agency easier with less regulatory documentation. It is up to you to make the most use of these situations and understand your rights and the programs that are being given to you.