B. Braun US Pharmaceutical Manufacturing, LLC
⚠️ High Risk
FEI: 2021236 • Irvine, CA • UNITED STATES
FEI Number
2021236
Location
Irvine, CA
Country
UNITED STATESAddress
2525 Mcgaw Ave, , Irvine, CA, 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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/19/2024 | 55RP74DEXTROSE (PHARMACEUTIC NECESSITY) | 179AGR RX | Division of Northern Border Imports (DNBI) |
| 11/19/2024 | 65RDK19SODIUM CHLORIDE (REPLENISHER) | 179AGR RX | Division of Northern Border Imports (DNBI) |
| 11/19/2024 | 65RDK19SODIUM CHLORIDE (REPLENISHER) | 179AGR RX | Division of Northern Border Imports (DNBI) |
| 11/15/2024 | 64ZDK01CALCIUM CHLORIDE, DEXTROSE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, SODIUM LACTATE, PERITONEAL DIALYSIS | 179AGR RX | Division of Northern Border Imports (DNBI) |
| 11/15/2024 | 65RDK19SODIUM CHLORIDE (REPLENISHER) | 179AGR RX | Division of Northern Border Imports (DNBI) |
| 11/15/2024 | 65RDK19SODIUM CHLORIDE (REPLENISHER) | 179AGR RX | Division of Northern Border Imports (DNBI) |
| 11/15/2024 | 65RDK19SODIUM CHLORIDE (REPLENISHER) | 179AGR RX | Division of Northern Border Imports (DNBI) |
| 11/12/2024 | 65RCN99REPLENISHER N.E.C. | 179AGR RX | Division of Southeast Imports (DSEI) |
| 11/12/2024 | 65RCN99REPLENISHER N.E.C. | 179AGR RX | Division of Southeast Imports (DSEI) |
| 11/12/2024 | 65RCN99REPLENISHER N.E.C. | 179AGR RX | Division of Southeast Imports (DSEI) |
| 11/12/2024 | 65RCN99REPLENISHER N.E.C. | 179AGR RX | Division of Southeast Imports (DSEI) |
| 11/12/2024 | 65RCN99REPLENISHER N.E.C. | 179AGR RX | Division of Southeast Imports (DSEI) |
| 8/18/2023 | 65RDN14POTASSIUM CHLORIDE (REPLENISHER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/29/2022 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 1/9/2020 | 65FAK02WATER, PURIFIED, U.S.P. (PHARMACEUTIC AID) | 179AGR RX | Division of Northern Border Imports (DNBI) |
| 1/16/2015 | 65RCY12POTASSIC SALINE (INJECTION) (REPLENISHER) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 5/27/2008 | 65FCN04WATER (PHARM AID) FOR INJ, STERILE, U.S.P. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 11/27/2006 | 65HDN04HETASTARCH (PLASMA VOLUME EXTENDER) | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is B. Braun US Pharmaceutical Manufacturing, LLC's FDA import refusal history?
B. Braun US Pharmaceutical Manufacturing, LLC (FEI: 2021236) has 18 FDA import refusal record(s) in our database, spanning from 11/27/2006 to 11/19/2024.
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 US Pharmaceutical Manufacturing, LLC's FEI number is 2021236.
What types of violations has B. Braun US Pharmaceutical Manufacturing, LLC received?
B. Braun US Pharmaceutical Manufacturing, LLC 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 US Pharmaceutical Manufacturing, LLC come from?
All FDA import refusal data for B. Braun US Pharmaceutical Manufacturing, LLC 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.