Fresenius Kabi USA, LLC
⚠️ Moderate Risk
FEI: 3002733956 • Lake Zurich, IL • UNITED STATES
FEI Number
3002733956
Location
Lake Zurich, IL
Country
UNITED STATESAddress
3 Corporate Dr, , Lake Zurich, IL, United States
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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 |
|---|---|---|---|
| 2/12/2024 | 62OCK44METOPROLOL TARTRATE (ANTI-HYPERTENSIVE - PART II) | 179AGR RX | Division of Northeast Imports (DNEI) |
| 2/12/2024 | 60QCK79BUPIVACAINE HYDROCHLORIDE (ANESTHETIC) | 179AGR RX | Division of Northeast Imports (DNEI) |
| 3/22/2023 | 65RDK19SODIUM CHLORIDE (REPLENISHER) | 179AGR RX | Division of West Coast Imports (DWCI) |
| 3/22/2023 | 62CDK30HYDRALAZINE HCL (ANTI-HYPERTENSIVE) | 179AGR RX | Division of West Coast Imports (DWCI) |
| 3/22/2023 | 56IDA76AZITHROMYCIN (MACAROLIDES) | 179AGR RX | Division of West Coast Imports (DWCI) |
| 7/22/2021 | 65DCK06OXYTOCIN (INJECTION) (OXYTOCIC) | Division of Southeast Imports (DSEI) | |
| 7/8/2020 | 55YF99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/30/2018 | 64UCY04CILASTATIN SODIUM/IMIPENEM (INHIBITOR (DECARBOXYLASE)) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/6/2015 | 61LDY08HEPARIN SODIUM (ANTI-COAGULANT) | 179AGR RX | Cincinnati District Office (CIN-DO) |
| 5/17/2013 | 61LCP08HEPARIN SODIUM (ANTI-COAGULANT) | 179AGR RX | Baltimore District Office (BLT-DO) |
| 4/28/2010 | 65FCK04WATER (PHARM AID) FOR INJ, STERILE, U.S.P. | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Fresenius Kabi USA, LLC's FDA import refusal history?
Fresenius Kabi USA, LLC (FEI: 3002733956) has 11 FDA import refusal record(s) in our database, spanning from 4/28/2010 to 2/12/2024.
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. Fresenius Kabi USA, LLC's FEI number is 3002733956.
What types of violations has Fresenius Kabi USA, LLC received?
Fresenius Kabi USA, 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 Fresenius Kabi USA, LLC come from?
All FDA import refusal data for Fresenius Kabi USA, 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.