FDA Inspection 617539 — Janssen Biotech Inc.
The FDA completed an inspection of Janssen Biotech Inc. on October 2, 2009 in Horsham, PA. 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
- October 2, 2009
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Horsham, PA (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)