ImportRefusal LogoImportRefusal

Sundar Diabetics Dezire Pvt Ltd

⚠️ Moderate Risk

FEI: 3013877008 • Chennai, Tamil Nadu • INDIA

FEI

FEI Number

3013877008

📍

Location

Chennai, Tamil Nadu

🇮🇳

Country

INDIA
🏢

Address

434, , Chennai, Tamil Nadu, India

Moderate Risk

FDA Import Risk Assessment

32.1
LowModerateHighCritical

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

Statistics

6
Total Refusals
6
Unique Violations
1/5/2018
Latest Refusal
1/5/2018
Earliest Refusal

Score Breakdown

Violation Severity
41.9×40%
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

3286×

USUAL NAME

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)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be.

3215×

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.

642×

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.

33001×

ALLERGEN

the label fails to declare all major food allergens present in the product, as required by section 403(w)(1).

38651×

COLORLABEL

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.

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
1/5/2018
07DYY99BREAD SNACKS, N.E.C.
328USUAL NAME
3300ALLERGEN
Division of Southeast Imports (DSEI)
1/5/2018
07DYY99BREAD SNACKS, N.E.C.
321LACKS N/C
328USUAL NAME
3865COLORLABEL
64YELLOW #5
Division of Southeast Imports (DSEI)
1/5/2018
07DYY99BREAD SNACKS, N.E.C.
321LACKS N/C
328USUAL NAME
482NUTRIT LBL
Division of Southeast Imports (DSEI)
1/5/2018
07DYY99BREAD SNACKS, N.E.C.
321LACKS N/C
328USUAL NAME
64YELLOW #5
Division of Southeast Imports (DSEI)
1/5/2018
07DYY99BREAD SNACKS, N.E.C.
321LACKS N/C
328USUAL NAME
Division of Southeast Imports (DSEI)
1/5/2018
07DYY99BREAD SNACKS, N.E.C.
321LACKS N/C
328USUAL NAME
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Sundar Diabetics Dezire Pvt Ltd's FDA import refusal history?

Sundar Diabetics Dezire Pvt Ltd (FEI: 3013877008) has 6 FDA import refusal record(s) in our database, spanning from 1/5/2018 to 1/5/2018.

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. Sundar Diabetics Dezire Pvt Ltd's FEI number is 3013877008.

What types of violations has Sundar Diabetics Dezire Pvt Ltd received?

Sundar Diabetics Dezire Pvt Ltd has been cited for 6 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 Sundar Diabetics Dezire Pvt Ltd come from?

All FDA import refusal data for Sundar Diabetics Dezire Pvt 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.