FDA Inspection 1096761 — PolyPeptide Laboratories (Sweden) AB

PolyPeptide Laboratories (Sweden) AB — FEI 3002807004

The FDA completed an inspection of PolyPeptide Laboratories (Sweden) AB on April 10, 2019 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
April 10, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Limhamn (Sweden)

Additional Details

Mutual Recognition Agreement (MRA)