FDA Inspection 1064045 — GlaxoSmithKline Manufacturing S.p.A.

GlaxoSmithKline Manufacturing S.p.A. — FEI 3002807114

The FDA completed an inspection of GlaxoSmithKline Manufacturing S.p.A. on September 29, 2017 in Torrile. 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 29, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Torrile (Italy)

Additional Details

Mutual Recognition Agreement (MRA)