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 3006244497.
Observations2
Issue DateFebruary 11, 2026
StatusNo Warning Letter
Related Inspections10
Establishment Details
Firm
Janssen Cilag Manufacturing LLC
Location
Gurabo, Puerto Rico
FEI Number
3006244497
Product Type
Drugs
Issue Date
February 11, 2026
Country
United States
Inspection History, 2009 to 2026
NAI6
VAI4
NAI means No Action Indicated. VAI means Voluntary Action Indicated.
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