Excelsior Medical LLC
⚠️ High Risk
FEI: 1000122362 • Neptune, NJ • UNITED STATES
FEI Number
1000122362
Location
Neptune, NJ
Country
UNITED STATESAddress
1933 Heck Ave, , Neptune, NJ, 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
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).
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).
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.
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.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/20/2024 | 65RAK19SODIUM CHLORIDE (REPLENISHER) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 11/13/2024 | 65RAK19SODIUM CHLORIDE (REPLENISHER) | Division of Northern Border Imports (DNBI) | |
| 11/13/2024 | 65RAK19SODIUM CHLORIDE (REPLENISHER) | Division of Northern Border Imports (DNBI) | |
| 11/13/2024 | 65RAK19SODIUM CHLORIDE (REPLENISHER) | Division of Northern Border Imports (DNBI) | |
| 11/13/2024 | 65RAK19SODIUM CHLORIDE (REPLENISHER) | Division of Northern Border Imports (DNBI) | |
| 11/13/2024 | 65RAK19SODIUM CHLORIDE (REPLENISHER) | Division of Northern Border Imports (DNBI) | |
| 11/13/2024 | 65FCK03WATER, FOR INJECTION, U.S.P. (PHARMACEUTIC AID) | Division of Northern Border Imports (DNBI) | |
| 11/13/2024 | 65FCK03WATER, FOR INJECTION, U.S.P. (PHARMACEUTIC AID) | Division of Northern Border Imports (DNBI) | |
| 11/13/2024 | 65RAK19SODIUM CHLORIDE (REPLENISHER) | Division of Northern Border Imports (DNBI) | |
| 11/13/2024 | 65RAK19SODIUM CHLORIDE (REPLENISHER) | Division of Northern Border Imports (DNBI) | |
| 11/13/2024 | 65RAK19SODIUM CHLORIDE (REPLENISHER) | Division of Northern Border Imports (DNBI) | |
| 11/13/2024 | 65RAK19SODIUM CHLORIDE (REPLENISHER) | Division of Northern Border Imports (DNBI) | |
| 11/13/2024 | 65RAK19SODIUM CHLORIDE (REPLENISHER) | Division of Northern Border Imports (DNBI) | |
| 11/13/2024 | 65RAK19SODIUM CHLORIDE (REPLENISHER) | Division of Northern Border Imports (DNBI) | |
| 11/13/2024 | 65FCK03WATER, FOR INJECTION, U.S.P. (PHARMACEUTIC AID) | Division of Northern Border Imports (DNBI) | |
| 11/21/2022 | 80KYZSYRINGE, IRRIGATING | Division of Southeast Imports (DSEI) | |
| 10/31/2014 | 55RY55SODIUM CHLORIDE (PHARMACEUTIC NECESSITY - TONICITY AGENT) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Excelsior Medical LLC's FDA import refusal history?
Excelsior Medical LLC (FEI: 1000122362) has 17 FDA import refusal record(s) in our database, spanning from 10/31/2014 to 11/20/2024.
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. Excelsior Medical LLC's FEI number is 1000122362.
What types of violations has Excelsior Medical LLC received?
Excelsior Medical LLC has been cited for 5 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 Excelsior Medical LLC come from?
All FDA import refusal data for Excelsior Medical 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.