FDA Inspection 1115591 — Bial Portela & Ca. S.A.
The FDA completed an inspection of Bial Portela & Ca. S.A. on May 10, 2019 in South Mamede Do Coronado. 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 10, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- South Mamede Do Coronado (Portugal)
Additional Details
Mutual Recognition Agreement (MRA)