FDA Inspection 800384 — GSK LLC (GlaxoSmithKline)

GSK LLC (GlaxoSmithKline) — FEI 3006810568

The FDA completed an inspection of GSK LLC (GlaxoSmithKline) on September 19, 2012 in Collegeville, 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
September 19, 2012
Fiscal Year
2012
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Collegeville, PA (United States)

Additional Details

Risk Evaluation and Mitigation Strategies (REMS)