FDA Inspection 1247046 — Rottendorf Pharma Gmbh

Rottendorf Pharma Gmbh — FEI 3003732290

The FDA completed an inspection of Rottendorf Pharma Gmbh on May 6, 2021 in Ennigerloh. 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 6, 2021
Fiscal Year
2021
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Ennigerloh (Germany)

Additional Details

Mutual Recognition Agreement (MRA)