B Braun Medical Inc
⚠️ High Risk
FEI: 2521402 • Bethlehem, PA • UNITED STATES
FEI Number
2521402
Location
Bethlehem, PA
Country
UNITED STATESAddress
824 12th Ave, , Bethlehem, PA, United States
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/10/2025 | 65RCK19SODIUM CHLORIDE (REPLENISHER) | 179AGR RX | Division of Northern Border Imports (DNBI) |
| 3/10/2025 | 65RCK19SODIUM CHLORIDE (REPLENISHER) | 179AGR RX | Division of Northern Border Imports (DNBI) |
| 2/5/2025 | 65RCK19SODIUM CHLORIDE (REPLENISHER) | 179AGR RX | Division of Northern Border Imports (DNBI) |
| 2/5/2025 | 65RCK19SODIUM CHLORIDE (REPLENISHER) | 179AGR RX | Division of Northern Border Imports (DNBI) |
| 2/5/2025 | 65RCK19SODIUM CHLORIDE (REPLENISHER) | 179AGR RX | Division of Northern Border Imports (DNBI) |
| 2/5/2025 | 65RCK19SODIUM CHLORIDE (REPLENISHER) | 179AGR RX | Division of Northern Border Imports (DNBI) |
| 1/28/2025 | 65RAK19SODIUM CHLORIDE (REPLENISHER) | 179AGR RX | Division of Northern Border Imports (DNBI) |
| 1/28/2025 | 65RAK19SODIUM CHLORIDE (REPLENISHER) | 179AGR RX | Division of Northern Border Imports (DNBI) |
| 1/28/2025 | 65RAK19SODIUM CHLORIDE (REPLENISHER) | 179AGR RX | Division of Northern Border Imports (DNBI) |
| 1/7/2025 | 55RP74DEXTROSE (PHARMACEUTIC NECESSITY) | 179AGR RX | Division of Northern Border Imports (DNBI) |
| 1/7/2025 | 55RP55SODIUM CHLORIDE (PHARMACEUTIC NECESSITY - TONICITY AGENT) | 179AGR RX | Division of Northern Border Imports (DNBI) |
| 1/7/2025 | 55RP55SODIUM CHLORIDE (PHARMACEUTIC NECESSITY - TONICITY AGENT) | 179AGR RX | Division of Northern Border Imports (DNBI) |
| 12/6/2024 | 65RCY19SODIUM CHLORIDE (REPLENISHER) | Division of Southeast Imports (DSEI) | |
| 5/17/2024 | 65RAY19SODIUM CHLORIDE (REPLENISHER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/17/2024 | 65RAY19SODIUM CHLORIDE (REPLENISHER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/28/2023 | 65RAY19SODIUM CHLORIDE (REPLENISHER) | Division of Southeast Imports (DSEI) | |
| 3/22/2023 | 65RDK19SODIUM CHLORIDE (REPLENISHER) | 179AGR RX | Division of West Coast Imports (DWCI) |
| 2/16/2023 | 65RIY19SODIUM CHLORIDE (REPLENISHER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/11/2023 | 78KPODIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is B Braun Medical Inc's FDA import refusal history?
B Braun Medical Inc (FEI: 2521402) has 19 FDA import refusal record(s) in our database, spanning from 1/11/2023 to 3/10/2025.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. B Braun Medical Inc's FEI number is 2521402.
What types of violations has B Braun Medical Inc received?
B Braun Medical Inc has been cited for 4 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about B Braun Medical Inc come from?
All FDA import refusal data for B Braun Medical Inc is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.