International Medication Systems Ltd.
⚠️ Moderate Risk
FEI: 2016148 • South El Monte, CA • UNITED STATES
FEI Number
2016148
Location
South El Monte, CA
Country
UNITED STATESAddress
1886 Santa Anita Ave, , South El Monte, CA, 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
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).
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.
DE/RX KIT
The article appears to be a combination medical device/prescription drug kit for which the prescription drug component was manufactured in the U.S., is 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.
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 |
|---|---|---|---|
| 7/22/2024 | 60CCY04EPINEPHRINE (ADRENERGIC) | Division of Southeast Imports (DSEI) | |
| 8/4/2008 | 61KCP05ATROPINE SULFATE (ANTI-CHOLINERGIC) | Chicago District Office (CHI-DO) | |
| 8/4/2008 | 77KCOINHALER, NASAL | 118NOT LISTED | Chicago District Office (CHI-DO) |
| 5/23/2008 | 61KCP05ATROPINE SULFATE (ANTI-CHOLINERGIC) | Chicago District Office (CHI-DO) | |
| 5/23/2008 | 77KCOINHALER, NASAL | Chicago District Office (CHI-DO) | |
| 2/2/2006 | 61KCK05ATROPINE SULFATE (ANTI-CHOLINERGIC) | 179AGR RX | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is International Medication Systems Ltd.'s FDA import refusal history?
International Medication Systems Ltd. (FEI: 2016148) has 6 FDA import refusal record(s) in our database, spanning from 2/2/2006 to 7/22/2024.
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. International Medication Systems Ltd.'s FEI number is 2016148.
What types of violations has International Medication Systems Ltd. received?
International Medication Systems Ltd. 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 International Medication Systems Ltd. come from?
All FDA import refusal data for International Medication Systems Ltd. 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.