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Fernanda Gonzalez

⚠️ Moderate Risk

FEI: 3004106986 • Arroyo Hondo Santo Domiingo • DOMINICAN REPUBLIC

FEI

FEI Number

3004106986

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Location

Arroyo Hondo Santo Domiingo

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Address

Calle Bienvenido Gacia Gautie Edig Paula, , Arroyo Hondo Santo Domiingo, , Dominican Republic

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
8/21/2003
Latest Refusal
8/21/2003
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

4721×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

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
8/21/2003
66VCA99MISCELLANEOUS PATENT MEDICINES, ETC.
472NO ENGLISH
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Fernanda Gonzalez's FDA import refusal history?

Fernanda Gonzalez (FEI: 3004106986) has 1 FDA import refusal record(s) in our database, spanning from 8/21/2003 to 8/21/2003.

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. Fernanda Gonzalez's FEI number is 3004106986.

What types of violations has Fernanda Gonzalez received?

Fernanda Gonzalez has been cited for 2 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 Fernanda Gonzalez come from?

All FDA import refusal data for Fernanda Gonzalez 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.