Wednesday, April 20, 2011

FDA Dispute Resolution

I emailed the FDA Office of the Ombudsman  at to escalate my FDA complaint in regards to the March 23 FDA Enforcement Report and the information it contained.

According to the FDA site the Office of the Ombudsman is for dispute resolution:
The Office of the Ombudsman is a resource for individuals and for companies when they are experiencing problems with the regulatory process or with the application of FDA policies or procedures. The Office of the Ombudsman provides assistance if there are problems or concerns that are not being addressed, or cannot be addressed, at the center or district level, or when there are concerns about raising an issue at that level. If requested, confidentiality will be maintained by the Office of the Ombudsman to the greatest extent possible.
I outlined my concerns about the information provided to the FDA about the recall, including the communication of the recall by the company and the possibility that the reach exceeds the 500 units in commerce that was reported to the FDA. I included a link to the post with supporting information and I identified myself by name.

There is no clear turnaround time for response, but I plan to make a follow up call in a week to (301) 796-8530 if I have not heard back about my concerns with the handling/reporting of the GlitterSniffer Cosmetics recall.

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