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 3004971302.
Observations13
Issue DateDecember 03, 2015
StatusNo Warning Letter
Establishment TypeManufacturer
Related Inspections2
Establishment Details
Firm
Auxigen Pharmaceutical, LLC
Issued To
American Family Pharmacy, LLC
Location
Indianapolis, Indiana, United States
FEI Number
3004971302
Establishment Type
Manufacturer
Product Type
Drugs
Issue Date
December 03, 2015
Country
United States
Inspection History, 2011 to 2014
VAI1
OAI1
VAI means Voluntary Action Indicated. OAI means Official Action Indicated.