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Rosa Taheya Gutierrez

⚠️ Moderate Risk

FEI: 3004207144 • Santo Domingo • DOMINICAN REPUBLIC

FEI

FEI Number

3004207144

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Location

Santo Domingo

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🏢

Address

Calle 3ra # 41 La Agustina, , Santo Domingo, , Dominican Republic

Moderate Risk

FDA Import Risk Assessment

43.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
3
Unique Violations
5/12/2004
Latest Refusal
2/5/2004
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

1971×

COSM COLOR

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).

481×

NEEDS ACID

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health due to inadequate acidification.

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
5/12/2004
28LGY99MIXED SPICES AND SEASONINGS, LIQUID, WITH SALT, N.E.C.
48NEEDS ACID
Florida District Office (FLA-DO)
2/5/2004
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
197COSM COLOR
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Rosa Taheya Gutierrez's FDA import refusal history?

Rosa Taheya Gutierrez (FEI: 3004207144) has 2 FDA import refusal record(s) in our database, spanning from 2/5/2004 to 5/12/2004.

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. Rosa Taheya Gutierrez's FEI number is 3004207144.

What types of violations has Rosa Taheya Gutierrez received?

Rosa Taheya Gutierrez has been cited for 3 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 Rosa Taheya Gutierrez come from?

All FDA import refusal data for Rosa Taheya Gutierrez 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.