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FDA Inspection 1273228 — PolyPeptide Laboratories (Sweden) AB

PolyPeptide Laboratories (Sweden) AB — FEI 3002807004

The FDA completed an inspection of PolyPeptide Laboratories (Sweden) AB on January 23, 2025 in Limhamn. 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
January 23, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Limhamn (Sweden)

Additional Details

Mutual Recognition Agreement (MRA)

Facility

Other inspections at this facility

  • 1096761 (VAI Wed Apr 10 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 976058 (NAI Fri May 27 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 854145 (VAI Fri Sep 20 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 618582 (NAI Wed Oct 07 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources