Source: FDA inspection record. Confirmed against FDA's published inspection data for this establishment and inspection date. FDA has published the inspection and what it cited, but not the form itself, which usually takes six to twelve months. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 2083424.
Observations2
Issue DateJune 11, 2018
StatusNo Warning Letter
Related Inspections2
Establishment Details
Firm
Sudhir Gupta, M.D., Ph.D., M.A.C.P
Location
Irvine, California, United States
FEI Number
2083424
Product Type
Biologics
Issue Date
June 11, 2018
Country
United States
Inspection History, 2009 to 2018
NAI1
VAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated.