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Caramelos Duros de Mexico, S.A. de CV

⚠️ Moderate Risk

FEI: 3005257091 • Tijuana, Baja California • MEXICO

FEI

FEI Number

3005257091

📍

Location

Tijuana, Baja California

🇲🇽

Country

MEXICO
🏢

Address

Calle 5 Sur 148, Parque Industrial Ciudad Industrial, Tijuana, Tijuana, Baja California, Mexico

Moderate Risk

FDA Import Risk Assessment

48.8
LowModerateHighCritical

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

Statistics

33
Total Refusals
5
Unique Violations
10/6/2015
Latest Refusal
8/1/2011
Earliest Refusal

Score Breakdown

Violation Severity
59.9×40%
Refusal Volume
56.7×30%
Recency
0.0×20%
Frequency
78.9×10%
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

27428×

COLOR LBLG

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

1126×

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).

4736×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

3285×

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.

2601×

FALSE

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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.

Refusal History

DateProductViolationsDivision
10/6/2015
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Southwest Import District Office (SWI-DO)
10/6/2015
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Southwest Import District Office (SWI-DO)
10/6/2015
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Southwest Import District Office (SWI-DO)
10/6/2015
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Southwest Import District Office (SWI-DO)
10/6/2015
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Southwest Import District Office (SWI-DO)
10/6/2015
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Southwest Import District Office (SWI-DO)
10/6/2015
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Southwest Import District Office (SWI-DO)
10/6/2015
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Southwest Import District Office (SWI-DO)
10/6/2015
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Southwest Import District Office (SWI-DO)
10/6/2015
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Southwest Import District Office (SWI-DO)
10/6/2015
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Southwest Import District Office (SWI-DO)
10/6/2015
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Southwest Import District Office (SWI-DO)
10/6/2015
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Southwest Import District Office (SWI-DO)
10/6/2015
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Southwest Import District Office (SWI-DO)
10/6/2015
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Southwest Import District Office (SWI-DO)
10/6/2015
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Southwest Import District Office (SWI-DO)
10/6/2015
33EGT06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Southwest Import District Office (SWI-DO)
10/6/2015
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Southwest Import District Office (SWI-DO)
10/6/2015
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Southwest Import District Office (SWI-DO)
10/6/2015
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Southwest Import District Office (SWI-DO)
10/6/2015
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Southwest Import District Office (SWI-DO)
10/6/2015
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Southwest Import District Office (SWI-DO)
10/6/2015
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Southwest Import District Office (SWI-DO)
10/6/2015
33EGT06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Southwest Import District Office (SWI-DO)
10/6/2015
33EGT06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Southwest Import District Office (SWI-DO)
10/6/2015
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Southwest Import District Office (SWI-DO)
3/25/2015
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
274COLOR LBLG
Philadelphia District Office (PHI-DO)
1/26/2015
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
260FALSE
274COLOR LBLG
473LABELING
Detroit District Office (DET-DO)
8/1/2011
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
328USUAL NAME
473LABELING
Southwest Import District Office (SWI-DO)
8/1/2011
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
328USUAL NAME
473LABELING
Southwest Import District Office (SWI-DO)
8/1/2011
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
328USUAL NAME
473LABELING
Southwest Import District Office (SWI-DO)
8/1/2011
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
328USUAL NAME
473LABELING
Southwest Import District Office (SWI-DO)
8/1/2011
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
328USUAL NAME
473LABELING
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Caramelos Duros de Mexico, S.A. de CV's FDA import refusal history?

Caramelos Duros de Mexico, S.A. de CV (FEI: 3005257091) has 33 FDA import refusal record(s) in our database, spanning from 8/1/2011 to 10/6/2015.

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. Caramelos Duros de Mexico, S.A. de CV's FEI number is 3005257091.

What types of violations has Caramelos Duros de Mexico, S.A. de CV received?

Caramelos Duros de Mexico, S.A. de CV 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 Caramelos Duros de Mexico, S.A. de CV come from?

All FDA import refusal data for Caramelos Duros de Mexico, S.A. de CV 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.