MAXROTH IMPEX PVT LTD
⚠️ Moderate Risk
FEI: 3006345820 • Ahmedabad, Gujarat • INDIA
FEI Number
3006345820
Location
Ahmedabad, Gujarat
Country
INDIAAddress
B Neelmani Chambers, 2nd Floor; Ashram Road; H Sales, Ahmedabad, Gujarat, 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).
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).
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
SALMONELLA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain Salmonella, a poisonous and deleterious substance which may render it injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/26/2013 | 28AGH15CORIANDER, WHOLE (SPICE) | 249FILTHY | New York District Office (NYK-DO) |
| 8/14/2012 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Chicago District Office (CHI-DO) | |
| 8/14/2012 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Chicago District Office (CHI-DO) | |
| 8/14/2012 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Chicago District Office (CHI-DO) | |
| 8/14/2012 | 66VAJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Chicago District Office (CHI-DO) | |
| 2/16/2010 | 28BGT54PEPPER, BLACK, GROUND, CRACKED (SPICE) | New York District Office (NYK-DO) | |
| 2/16/2010 | 28BGT54PEPPER, BLACK, GROUND, CRACKED (SPICE) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is MAXROTH IMPEX PVT LTD's FDA import refusal history?
MAXROTH IMPEX PVT LTD (FEI: 3006345820) has 7 FDA import refusal record(s) in our database, spanning from 2/16/2010 to 4/26/2013.
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. MAXROTH IMPEX PVT LTD's FEI number is 3006345820.
What types of violations has MAXROTH IMPEX PVT LTD received?
MAXROTH IMPEX PVT LTD 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 MAXROTH IMPEX PVT LTD come from?
All FDA import refusal data for MAXROTH IMPEX PVT 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.