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 3010087152.
Observations14
Issue DateOctober 23, 2015
StatusNo Warning Letter
Establishment TypeProducer of Sterile Drug Products
Related Inspections7
Establishment Details
Firm
Downing Labs, LLC
Location
Dallas, Texas, United States
FEI Number
3010087152
Establishment Type
Producer of Sterile Drug Products
Product Type
Drugs
Issue Date
October 23, 2015
Country
United States
Inspection History, 2013 to 2018
VAI1
OAI6
VAI means Voluntary Action Indicated. OAI means Official Action Indicated.
Talk to a Specialist