FDA Inspection 1159666 — AGC Pharma Chemicals Europe, S.L.U.

AGC Pharma Chemicals Europe, S.L.U. — FEI 3002806459

The FDA completed an inspection of AGC Pharma Chemicals Europe, S.L.U. on May 25, 2018 in Malgrat De Mar. 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
May 25, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Malgrat De Mar (Spain)

Additional Details

Mutual Recognition Agreement (MRA)