This may be old information for many, but it was new to me. Sharing new FDA Contact Information
Your firm now has new FDA contacts to correspond with regarding your medical device inspections. Your inspections are now managed by the Office of Regulatory Affairs' Office of Medical Device and Radiological Health Operations (OMDRHO) Division 1 - East.
What is the Office of Medical Device and Radiological Health Operations
(OMDRHO) Division 1 - East?
This Program Division solely works with medical devices. It covers the states of: CT, DE, IN, KY, MA, ME, MD, Ml, NH, NJ, NY, OH, PA, RI, VA, VT, \/N and the District of Columbia.
Who do I contact following my FDA inspection?
E-mail your inspection-related correspondence to the email address listed below. A copy will be sent to the home District where your firm is located. Thumb drive or compact disc (cd) may be sent to the address below.
-mail correspondence to
oradevices1firmresponse@fda.hhs.govU.S. Food and Drug Administration
Office of Medical Device and Radiological Health Operations Division 1 - East ATTN: OMDRHO Div1 Correspondence
One Montvale Avenue
Stoneham, MA 02180
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Gregory Kleinert
Biocoat, Inc.
Warrington PA
United States
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