Khushi Exports
⚠️ Moderate Risk
FEI: 3004620875 • Barado • INDIA
FEI Number
3004620875
Location
Barado
Country
INDIAAddress
E-83 Epip Zone Gidc Manjusar , Savli, , Barado, , India
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
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.
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/1/2008 | 41ECE99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE) | 482NUTRIT LBL | New York District Office (NYK-DO) |
| 1/25/2005 | 76EIHPOWDER, PORCELAIN | New York District Office (NYK-DO) | |
| 11/10/2004 | 24CCE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), WITH SAUCE | 62NEEDS FCE | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Khushi Exports's FDA import refusal history?
Khushi Exports (FEI: 3004620875) has 3 FDA import refusal record(s) in our database, spanning from 11/10/2004 to 7/1/2008.
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. Khushi Exports's FEI number is 3004620875.
What types of violations has Khushi Exports received?
Khushi Exports 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 Khushi Exports come from?
All FDA import refusal data for Khushi Exports 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.