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FDA Inspection 1029739 — Janssen Cilag Manufacturing LLC

Janssen Cilag Manufacturing LLC — FEI 3006244497

The FDA completed an inspection of Janssen Cilag Manufacturing LLC on August 7, 2017 in Gurabo, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 7, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Gurabo, PR (United States)

Facility

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  • 1158642 (VAI Tue Nov 23 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 998481 (NAI Fri Jan 13 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 872370 (NAI Mon Feb 24 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 854433 (NAI Wed Oct 23 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources