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Regal Sweets

⚠️ Moderate Risk

FEI: 3004108463 • Mumbai • INDIA

FEI

FEI Number

3004108463

📍

Location

Mumbai

🇮🇳

Country

INDIA
🏢

Address

Irla Society Road, , Mumbai, , India

Moderate Risk

FDA Import Risk Assessment

43.0
LowModerateHighCritical

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

Statistics

8
Total Refusals
4
Unique Violations
12/8/2003
Latest Refusal
11/17/2003
Earliest Refusal

Score Breakdown

Violation Severity
61.0×40%
Refusal Volume
35.3×30%
Recency
0.0×20%
Frequency
80.0×10%
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

114×

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).

2744×

COLOR LBLG

The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.

3241×

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)).

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.

Refusal History

DateProductViolationsDivision
12/8/2003
33LGY99SOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
274COLOR LBLG
324NO ENGLISH
Chicago District Office (CHI-DO)
12/8/2003
33LGY99SOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
274COLOR LBLG
Chicago District Office (CHI-DO)
12/8/2003
33LGY99SOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
274COLOR LBLG
Chicago District Office (CHI-DO)
12/8/2003
33LGY99SOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
274COLOR LBLG
Chicago District Office (CHI-DO)
12/8/2003
33LGY99SOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
64YELLOW #5
Chicago District Office (CHI-DO)
11/17/2003
33LGY99SOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
Chicago District Office (CHI-DO)
11/17/2003
33LGY99SOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
Chicago District Office (CHI-DO)
11/17/2003
33LGY99SOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is Regal Sweets's FDA import refusal history?

Regal Sweets (FEI: 3004108463) has 8 FDA import refusal record(s) in our database, spanning from 11/17/2003 to 12/8/2003.

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. Regal Sweets's FEI number is 3004108463.

What types of violations has Regal Sweets received?

Regal Sweets 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 Regal Sweets come from?

All FDA import refusal data for Regal Sweets 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.