Source: FDA, document on file. FDA released the Form 483 itself. The document linked above is our copy of FDA's file, stored by us so the link cannot break, and FDA's own copy is linked beside it. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 1000220451.
Observations4
Issue DateJuly 17, 2015
StatusNo Warning Letter
Establishment TypeInstitutional Review Board
Related Inspections3
Establishment Details
Firm
BRI Institutional Review Board, Inc.
Issued To
Burzynski Research Institute/ IRB
Location
Houston, Texas, United States
FEI Number
1000220451
Establishment Type
Institutional Review Board
Product Type
Drugs
Issue Date
July 17, 2015
Country
United States
Inspection History, 2008 to 2013
VAI1
OAI2
VAI means Voluntary Action Indicated. OAI means Official Action Indicated.
Talk to a Specialist