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 3001833549.
Observations16
Issue DateJuly 10, 2015
StatusNo Warning Letter
Establishment TypeSterile Drug Manufacturer
Related Inspections10
Establishment Details
Firm
Fresenius Kabi USA, LLC
Issued To
APP Pharmaceuticals
Location
Grand Island, New York, United States
FEI Number
3001833549
Establishment Type
Sterile Drug Manufacturer
Product Type
Drugs
Issue Date
July 10, 2015
Country
United States
Inspection History, 2011 to 2023
NAI1
VAI7
OAI2
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.
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