Contact the
ORA Ombudsman at 844-871-4536 and
ORAOmbudsman@fda.hhs.gov
My staff used to be responsible for that Close Out mailbox, but since the staff was dissolved in Program Alignment, I was never told who (if anyone) it was reassigned to. I'm sorry you didn't get a response.
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Andrea Chamblee Esq., RAC, FRAPS
This information and views expressed are provided in my capacity as an FDA and compliance professor at Johns Hopkins and George Washington universities, and do not necessarily represent the official views of the agency or the United States. Consult the Agency for an official position.
Silver Spring MD
United States
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Original Message:
Sent: 23-Jul-2020 11:01
From: Anonymous Member
Subject: Warning Letter Close Out
This message was posted by a user wishing to remain anonymous
My company was issued a warning letter in July 2018 and had a successful follow-up inspection with all actions found effective and no further findings in January 2020. Since the inspection, we have not heard a single word from FDA and have tried to contact them multiple times through the WLCloseOutProcess@fda.hhs.gov email, but have not received any response. We have also left a voice message with the regional Dept of Compliance with no response. Does anyone have tips or ideas on how to get in contact with the FDA in regards to warning letter status and close out?