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B.S. Trade International

⚠️ Moderate Risk

FEI: 3005271110 • Chittagong, Chittagong zila • BANGLADESH

FEI

FEI Number

3005271110

📍

Location

Chittagong, Chittagong zila

🇧🇩

Country

BANGLADESH
🏢

Address

222/228 Mojaher Building, 2nd Floor, Chittagong, Chittagong zila, Bangladesh

Moderate Risk

FDA Import Risk Assessment

35.7
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

4
Total Refusals
5
Unique Violations
7/10/2009
Latest Refusal
5/15/2006
Earliest Refusal

Score Breakdown

Violation Severity
66.7×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
12.7×10%
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

2382×

UNSAFE ADD

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.

22801×

DIRSEXMPT

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.

3241×

NO ENGLISH

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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

751×

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).

Refusal History

DateProductViolationsDivision
7/10/2009
54FCT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
324NO ENGLISH
New York District Office (NYK-DO)
6/24/2009
26CYT11MUSTARD OIL, REFINED, SINGLE INGREDIENT, SEE 28O FOR MUSTARD OIL AS A FLAVORING
238UNSAFE ADD
New York District Office (NYK-DO)
6/24/2009
26CYT11MUSTARD OIL, REFINED, SINGLE INGREDIENT, SEE 28O FOR MUSTARD OIL AS A FLAVORING
238UNSAFE ADD
New York District Office (NYK-DO)
5/15/2006
66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.
2280DIRSEXMPT
473LABELING
75UNAPPROVED
New York District Office (NYK-DO)

Frequently Asked Questions

What is B.S. Trade International's FDA import refusal history?

B.S. Trade International (FEI: 3005271110) has 4 FDA import refusal record(s) in our database, spanning from 5/15/2006 to 7/10/2009.

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. B.S. Trade International's FEI number is 3005271110.

What types of violations has B.S. Trade International received?

B.S. Trade International 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 B.S. Trade International come from?

All FDA import refusal data for B.S. Trade 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.