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FDA Inspection 735438 — Janssen Pharmaceuticals, dba Actelion Pharmaceutical

Janssen Pharmaceuticals, dba Actelion Pharmaceutical — FEI 3003498827

The FDA completed an inspection of Janssen Pharmaceuticals, dba Actelion Pharmaceutical on July 21, 2011 in South San Francisco, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 21, 2011
Fiscal Year
2011
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
South San Francisco, CA (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Citations

IDCFRDescription
673021 CFR 314.80(b)Failure to develop written procedures

Facility

Other inspections at this facility

  • 1091668 (NAI Thu Feb 28 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 988929 (VAI Wed Sep 21 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 873005 (VAI Wed Feb 12 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 599116 (OAI Mon Jul 20 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

FDA data resources