M.N. International
⚠️ Moderate Risk
FEI: 3011297853 • North Agarabad, Chittagong • BANGLADESH
FEI Number
3011297853
Location
North Agarabad, Chittagong
Country
BANGLADESHAddress
552, SHANTIBAG, R/A, ROAD 04, , North Agarabad, Chittagong, Bangladesh
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).
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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.
POISONORD
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a poisonous or deleterious substance which would ordinarily render the article injurious to health. Contains:
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.
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/8/2023 | 23AGT14BETEL NUT, IN SHELL | 3878POISONORD | Division of Northeast Imports (DNEI) |
| 8/10/2016 | 04AHT06VERMICELLI | 482NUTRIT LBL | New York District Office (NYK-DO) |
| 5/9/2012 | 54EDT99HERBALS & BOTANICAL TEAS, N.E.C. | Division of Northeast Imports (DNEI) | |
| 1/15/2009 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 1/15/2009 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 1/8/2009 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | New York District Office (NYK-DO) | |
| 7/17/2008 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 472NO ENGLISH | New York District Office (NYK-DO) |
| 7/17/2008 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 472NO ENGLISH | New York District Office (NYK-DO) |
| 3/10/2002 | 25HCF99MIXED VEGETABLES, WITH SAUCE, N.E.C. | 249FILTHY | New York District Office (NYK-DO) |
| 12/13/2001 | 21SCI14TAMARIND (SUBTROPICAL AND TROPICAL FRUIT) | 249FILTHY | New York District Office (NYK-DO) |
Frequently Asked Questions
What is M.N. International's FDA import refusal history?
M.N. International (FEI: 3011297853) has 10 FDA import refusal record(s) in our database, spanning from 12/13/2001 to 11/8/2023.
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. M.N. International's FEI number is 3011297853.
What types of violations has M.N. International received?
M.N. International has been cited for 8 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 M.N. International come from?
All FDA import refusal data for M.N. International 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.