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 2246848.
Observations11
Issue DateAugust 30, 2018
StatusNo Warning Letter
Establishment TypeDrug Manufacturer
Related Inspections10
Establishment Details
Firm
Akorn Operating Company LLC
Location
Somerset, New Jersey, United States
FEI Number
2246848
Establishment Type
Drug Manufacturer
Product Type
Drugs
Issue Date
August 30, 2018
Country
United States
Inspection History, 2009 to 2022
NAI3
VAI6
OAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.
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