Banyan International Corp
⚠️ Moderate Risk
FEI: 1619634 • Abilene, TX • UNITED STATES
FEI Number
1619634
Location
Abilene, TX
Country
UNITED STATESAddress
2118 East Ih-20, , Abilene, TX, 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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
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 |
|---|---|---|---|
| 2/18/2020 | 79OHOFIRST AID KIT WITHOUT DRUG | Division of Southeast Imports (DSEI) | |
| 1/9/2014 | 79LRRKIT, FIRST AID | Southwest Import District Office (SWI-DO) | |
| 1/9/2014 | 79LRRKIT, FIRST AID | Southwest Import District Office (SWI-DO) | |
| 1/9/2014 | 79LRRKIT, FIRST AID | Southwest Import District Office (SWI-DO) | |
| 1/9/2014 | 79LRRKIT, FIRST AID | Southwest Import District Office (SWI-DO) | |
| 1/9/2014 | 79LRRKIT, FIRST AID | Southwest Import District Office (SWI-DO) | |
| 1/9/2014 | 79LRRKIT, FIRST AID | Southwest Import District Office (SWI-DO) | |
| 1/9/2014 | 79LRRKIT, FIRST AID | Southwest Import District Office (SWI-DO) | |
| 1/9/2014 | 79LRRKIT, FIRST AID | Southwest Import District Office (SWI-DO) | |
| 1/9/2014 | 79LRRKIT, FIRST AID | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Banyan International Corp's FDA import refusal history?
Banyan International Corp (FEI: 1619634) has 10 FDA import refusal record(s) in our database, spanning from 1/9/2014 to 2/18/2020.
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. Banyan International Corp's FEI number is 1619634.
What types of violations has Banyan International Corp received?
Banyan International Corp has been cited for 3 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 Banyan International Corp come from?
All FDA import refusal data for Banyan International Corp 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.