Grand Wynn Manufacturing Ltd
⚠️ High Risk
FEI: 3015164161 • Tharkayta Township, Yangon • MYANMAR
FEI Number
3015164161
Location
Tharkayta Township, Yangon
Country
MYANMARAddress
No.50, 51th Yan Naing Swe Street, Set Hmu let Hmu Ward, Tharkayta Township, Yangon, Myanmar
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
SALMONELLA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain Salmonella, a poisonous and deleterious substance which may render it injurious to health.
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
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)).
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/26/2024 | 16AGD99FISH, N.E.C. | 9SALMONELLA | Division of West Coast Imports (DWCI) |
| 2/1/2021 | 16AGD99FISH, N.E.C. | Division of West Coast Imports (DWCI) | |
| 2/1/2021 | 16AGD99FISH, N.E.C. | Division of West Coast Imports (DWCI) | |
| 12/1/2016 | 16AGD99FISH, N.E.C. | 9SALMONELLA | Division of Northeast Imports (DNEI) |
| 8/27/2003 | 16AGD60SHEATFISH | Los Angeles District Office (LOS-DO) | |
| 8/27/2003 | 16AGH32SALMON (HUMPBACK, SILVER, KING, SOCKEYE, ETC.) | Los Angeles District Office (LOS-DO) | |
| 8/27/2003 | 16AGH64MUD FISH | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Grand Wynn Manufacturing Ltd's FDA import refusal history?
Grand Wynn Manufacturing Ltd (FEI: 3015164161) has 7 FDA import refusal record(s) in our database, spanning from 8/27/2003 to 1/26/2024.
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. Grand Wynn Manufacturing Ltd's FEI number is 3015164161.
What types of violations has Grand Wynn Manufacturing Ltd received?
Grand Wynn Manufacturing Ltd 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 Grand Wynn Manufacturing Ltd come from?
All FDA import refusal data for Grand Wynn Manufacturing 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.