Home / Inspections / 1158642

FDA Inspection 1158642 — Janssen Cilag Manufacturing LLC

Janssen Cilag Manufacturing LLC — FEI 3006244497

The FDA completed an inspection of Janssen Cilag Manufacturing LLC on November 23, 2021 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
November 23, 2021
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Gurabo, PR (United States)

Facility

Other inspections at this facility

  • 1302416 (VAI Wed Feb 11 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1029739 (VAI Mon Aug 07 2017 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