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FDA Inspection 1217692 — Przedsiebiorstwo Farmaceutyczne Jelfa SA

Przedsiebiorstwo Farmaceutyczne Jelfa SA — FEI 3004680543

The FDA completed an inspection of Przedsiebiorstwo Farmaceutyczne Jelfa SA on November 25, 2022 in Jelenia Gora. 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
November 25, 2022
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Jelenia Gora (Poland)

Additional Details

Mutual Recognition Agreement (MRA)

Facility

Other inspections at this facility

  • 1050200 (NAI Tue Mar 13 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 991418 (VAI Thu Sep 22 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 885404 (NAI Mon Jun 30 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 794037 (VAI Tue May 15 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 700751 (OAI Fri Oct 22 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

FDA data resources