ETC INTERNATIONAL
⚠️ Moderate Risk
FEI: 3006669661 • Dhaka, Dhaka • BANGLADESH
FEI Number
3006669661
Location
Dhaka, Dhaka
Country
BANGLADESHAddress
House # 21, Road # 1, Shekertek, Adabar, Dhaka, Dhaka, 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
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
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).
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)).
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.
LACKS FIRM
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(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/12/2010 | 26ACT12MUSTARD OIL, CRUDE, SEE 28O FOR MUSTARD OIL AS A FLAVORING | 238UNSAFE ADD | New York District Office (NYK-DO) |
| 3/12/2010 | 26ACT12MUSTARD OIL, CRUDE, SEE 28O FOR MUSTARD OIL AS A FLAVORING | 238UNSAFE ADD | New York District Office (NYK-DO) |
| 9/23/2009 | 26CGT11MUSTARD OIL, REFINED, SINGLE INGREDIENT, SEE 28O FOR MUSTARD OIL AS A FLAVORING | New York District Office (NYK-DO) | |
| 9/23/2009 | 26CGT11MUSTARD OIL, REFINED, SINGLE INGREDIENT, SEE 28O FOR MUSTARD OIL AS A FLAVORING | New York District Office (NYK-DO) | |
| 5/27/2009 | 54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 482NUTRIT LBL | New York District Office (NYK-DO) |
| 5/27/2009 | 65FAY99WATER N.E.C. (PHARMACEUTIC AID) | 473LABELING | New York District Office (NYK-DO) |
| 5/27/2009 | 65FAY99WATER N.E.C. (PHARMACEUTIC AID) | 473LABELING | New York District Office (NYK-DO) |
| 5/27/2009 | 54IDY02PSYLLIUM (FIBER) | 473LABELING | New York District Office (NYK-DO) |
| 5/27/2009 | 64ABY99DISINFECTANT N.E.C. | New York District Office (NYK-DO) | |
| 5/27/2009 | 64ABY99DISINFECTANT N.E.C. | New York District Office (NYK-DO) | |
| 5/27/2009 | 64ABY99DISINFECTANT N.E.C. | New York District Office (NYK-DO) | |
| 5/27/2009 | 64ABY99DISINFECTANT N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is ETC INTERNATIONAL's FDA import refusal history?
ETC INTERNATIONAL (FEI: 3006669661) has 12 FDA import refusal record(s) in our database, spanning from 5/27/2009 to 3/12/2010.
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. ETC INTERNATIONAL's FEI number is 3006669661.
What types of violations has ETC INTERNATIONAL received?
ETC 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 ETC INTERNATIONAL come from?
All FDA import refusal data for ETC 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.