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Thai Megamart Co Ltd

⚠️ Moderate Risk

FEI: 3010470281 • Bangkok • THAILAND

FEI

FEI Number

3010470281

📍

Location

Bangkok

🇹🇭

Country

THAILAND
🏢

Address

4-179 S Kubon 3 Kubon Rd, , Bangkok, , Thailand

Moderate Risk

FDA Import Risk Assessment

40.7
LowModerateHighCritical

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

Statistics

6
Total Refusals
4
Unique Violations
12/27/2013
Latest Refusal
12/27/2013
Earliest Refusal

Score Breakdown

Violation Severity
63.3×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
60.0×10%
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

3242×

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)).

752×

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).

1181×

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).

1971×

COSM COLOR

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).

Refusal History

DateProductViolationsDivision
12/27/2013
28JGT99MIXED SPICES AND SEASONING WITH SALT, N.E.C.
324NO ENGLISH
New Orleans District Office (NOL-DO)
12/27/2013
28JGT99MIXED SPICES AND SEASONING WITH SALT, N.E.C.
324NO ENGLISH
New Orleans District Office (NOL-DO)
12/27/2013
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
197COSM COLOR
New Orleans District Office (NOL-DO)
12/27/2013
66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
New Orleans District Office (NOL-DO)
12/27/2013
66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)
12/27/2013
66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Thai Megamart Co Ltd's FDA import refusal history?

Thai Megamart Co Ltd (FEI: 3010470281) has 6 FDA import refusal record(s) in our database, spanning from 12/27/2013 to 12/27/2013.

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. Thai Megamart Co Ltd's FEI number is 3010470281.

What types of violations has Thai Megamart Co Ltd received?

Thai Megamart Co 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 Thai Megamart Co Ltd come from?

All FDA import refusal data for Thai Megamart Co 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.