Mandalia Overseas Corporation
⚠️ Moderate Risk
FEI: 3008483562 • Mumbai, Maharashtra • INDIA
FEI Number
3008483562
Location
Mumbai, Maharashtra
Country
INDIAAddress
212 216 Sarang Street, , Mumbai, Maharashtra, 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
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).
FALSE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
LIST INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/1/2012 | 33EGT06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | 218LIST INGRE | Division of Northeast Imports (DNEI) |
| 6/26/2012 | 54FGT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 260FALSE | Division of Northeast Imports (DNEI) |
| 6/26/2012 | 54FGT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 260FALSE | Division of Northeast Imports (DNEI) |
| 12/7/2011 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 12/7/2011 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/22/2011 | 66VAS99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Mandalia Overseas Corporation's FDA import refusal history?
Mandalia Overseas Corporation (FEI: 3008483562) has 6 FDA import refusal record(s) in our database, spanning from 11/22/2011 to 8/1/2012.
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. Mandalia Overseas Corporation's FEI number is 3008483562.
What types of violations has Mandalia Overseas Corporation received?
Mandalia Overseas Corporation 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 Mandalia Overseas Corporation come from?
All FDA import refusal data for Mandalia Overseas Corporation 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.