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 3003563645.
Observations1
Issue DateDecember 19, 2012
StatusNo Warning Letter
Related Inspections10
Establishment Details
Firm
Ardena U.S. LLC
Location
Somerset, New Jersey, United States
FEI Number
3003563645
Product Type
Drugs
Issue Date
December 19, 2012
Country
United States
Inspection History, 2011 to 2025
NAI8
VAI2
NAI means No Action Indicated. VAI means Voluntary Action Indicated.
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