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FDA Inspection 1137635 — Sindan-Pharma SRL

Sindan-Pharma SRL — FEI 3005566806

The FDA completed an inspection of Sindan-Pharma SRL on April 5, 2018 in Bucharest. 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
April 5, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Bucharest (Romania)

Additional Details

Mutual Recognition Agreement (MRA)

Facility

Other inspections at this facility

  • 1247794 (NAI Fri Aug 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1019456 (VAI Fri Jul 28 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 933708 (NAI Mon Jun 15 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 874880 (NAI Tue Dec 10 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 720234 (NAI Wed Apr 06 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources