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Z Z M Co.,Ltd

⚠️ Moderate Risk

FEI: 3014144256 • Yangon, MM-06 • MYANMAR

FEI

FEI Number

3014144256

📍

Location

Yangon, MM-06

🇲🇲

Country

MYANMAR
🏢

Address

No 11, Sanchaung Street, Sanchaung Township, Yangon, MM-06, Myanmar

Moderate Risk

FDA Import Risk Assessment

46.5
LowModerateHighCritical

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

Statistics

7
Total Refusals
9
Unique Violations
11/1/2023
Latest Refusal
8/25/2023
Earliest Refusal

Score Breakdown

Violation Severity
45.7×40%
Refusal Volume
33.5×30%
Recency
56.1×20%
Frequency
70.0×10%
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

3243×

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)).

2563×

INCONSPICU

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)).

2182×

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.

621×

NEEDS FCE

It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).

641×

YELLOW #5

The food appears to bear or contain the color additive FD & C Yellow No. 5, which is not declared on the label per 21 CFR 74.705(a)(c) under section 721.

111×

UNSAFE COL

The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).

831×

NO PROCESS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.

3211×

LACKS N/C

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)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.

4821×

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

DateProductViolationsDivision
11/1/2023
03AGT99BREAD/ROLLS/BUNS, N.E.C.
256INCONSPICU
482NUTRIT LBL
Division of Northern Border Imports (DNBI)
11/1/2023
16YGT18BROTH, SEAFOOD (N.E.C.), FISHERY PRODUCTS, N.E.C.
256INCONSPICU
Division of Northern Border Imports (DNBI)
11/1/2023
37JGO03CHILI SAUCE
256INCONSPICU
Division of Northern Border Imports (DNBI)
11/1/2023
24TGT20MUSTARD GREENS (LEAF & STEM VEGETABLE)
218LIST INGRE
324NO ENGLISH
Division of Northern Border Imports (DNBI)
11/1/2023
24AFT99BEANS, CORN, AND PEA, N.E.C. (VEGETABLE)
218LIST INGRE
324NO ENGLISH
Division of Northern Border Imports (DNBI)
11/1/2023
29BHO04SOFT DRINK, MIXED FRUIT FLAVORED, CARBONATED
11UNSAFE COL
321LACKS N/C
64YELLOW #5
Division of Northern Border Imports (DNBI)
8/25/2023
31KCI05TEA, SPICE
324NO ENGLISH
62NEEDS FCE
83NO PROCESS
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is Z Z M Co.,Ltd's FDA import refusal history?

Z Z M Co.,Ltd (FEI: 3014144256) has 7 FDA import refusal record(s) in our database, spanning from 8/25/2023 to 11/1/2023.

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. Z Z M Co.,Ltd's FEI number is 3014144256.

What types of violations has Z Z M Co.,Ltd received?

Z Z M Co.,Ltd has been cited for 9 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 Z Z M Co.,Ltd come from?

All FDA import refusal data for Z Z M 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.