FDA Inspection 1337000 — Samsung Bioepis US Inc.
The FDA completed an inspection of Samsung Bioepis US Inc. on Sep 16, 2026 in Englewood Cliffs, NJ. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). Product area: Drugs.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Sep 16, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Englewood Cliffs, NJ (United States)
Additional Details
Risk Evaluation and Mitigation Strategies (REMS)