Posting a Company’s Response to a Warning Letter

Requests to Post Response on Internet

Did you know that if you had received a warning letter, you have the option as to whether you want your response posted on the FDA website or not. This is not a new initiative. It was tried back in 2003, see the following FDA update of June 24, 03 - NEW FDA PILOT PROGRAM – Posting Firm’s Responses to Warning Letters  (http://www.mdiconsultants.com/Section_NI/FDA/fda_update_June_24_2003.htm).

The FDA is now bringing this tried policy back.

In accordance with this policy, when a recipient of a Warning Letter requests that their response to that Warning Letter be posted on FDA's internet site and provides the response electronically in a word processing format, the agency will post that response. The agency has reserved the right not to post certain responses, such as when posting likely would mislead the public about the safety or efficacy of a regulated product

The office (district or center) that issued the Warning Letter must redact the response to the extent permitted by the Freedom of Information Act, and send a redacted copy of the response to FDA's Division of Freedom of Information, OMP, and the FOI office will then post the response to the above-referenced website. Submissions should be sent to the attention of Brenda Dorsey.

The agency policy on posting Warning Letter responses on the internet is found at: http://www.fda.gov/foi/warning.htm

Hopefully, you will not be in the unfortunate situation of being on the receiving end of a warning letter but if you are and you feel that having your response posted on the FDA website to provide your side of the story and to show your corrective actions will benefit your company, here is your opportunity.

Remember that FDA will review your response and make sure it addresses all points on the W/L and that your Corrective Actions are appropriate to correct all the observations made on the 483 and W/L.

If you have any questions concerning this FDA policy, just email us at info@mdiconsultants.com and reference Response to W/L.

Also, if you have a 483 or W/L you are in the midst of responding to give us a call and we can provide you some assistance to correctly address these FDA observations. Please see the mdi’s Insight Report Vol. 1, 2010, “How to Respond to an FDA 483 and Warning Letter”
http://www.mdiconsultants.com/Section_NI/Insights/insight_V12_is1.htm.