FDA Inspection 801000 — Bluepharma Industria Farmaceutica, S.A.

Bluepharma Industria Farmaceutica, S.A. — FEI 3007007549

The FDA completed an inspection of Bluepharma Industria Farmaceutica, S.A. on July 26, 2012 in Coimbra. 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 26, 2012
Fiscal Year
2012
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Coimbra (Portugal)

Citations

IDCFRDescription
363021 CFR 211.170(b)Drug product reserve containers