FDA Inspection 1123957 — Purac BioQuimica, S.A.
The FDA completed an inspection of Purac BioQuimica, S.A. on April 20, 2018 in Montmelo. 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 20, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Montmelo (Spain)
Additional Details
Mutual Recognition Agreement (MRA)