Home / Inspections / 1246782

FDA Inspection 1246782 — Rentschler Biopharma SE

Rentschler Biopharma SE — FEI 1000291122

The FDA completed an inspection of Rentschler Biopharma SE on May 5, 2023 in Laupheim. 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
May 5, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Laupheim (Germany)

Additional Details

Mutual Recognition Agreement (MRA)

Facility

Other inspections at this facility

  • 1160831 (VAI Fri Feb 26 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1102650 (NAI Fri Aug 09 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 999800 (VAI Tue Dec 06 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 933400 (VAI Tue Jun 16 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 853179 (VAI Fri Sep 20 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources