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FDA Inspection 853427 — Opella Healthcare International SAS

Opella Healthcare International SAS — FEI 3003492806

The FDA completed an inspection of Opella Healthcare International SAS on September 19, 2013 in Compiegne. 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, 2013
Fiscal Year
2013
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Compiegne (France)

Facility

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  • 1015497 (VAI Fri Jun 23 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 946883 (VAI Fri Sep 18 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 754638 (NAI Fri Oct 21 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources