FDA Inspection 909898 — Instituto Bioclon, S.A. de C.V.

Instituto Bioclon, S.A. de C.V. — FEI 3007581821

The FDA completed an inspection of Instituto Bioclon, S.A. de C.V. on November 20, 2014 in Cuautitlan. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 20, 2014
Fiscal Year
2015
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Cuautitlan (Mexico)