ANA MARIA RUIZ GONZALEZ
⚠️ Moderate Risk
FEI: 3013473131 • Zamora, Michoacan de Ocampo • MEXICO
FEI Number
3013473131
Location
Zamora, Michoacan de Ocampo
Country
MEXICOAddress
Calle Pino Suarez sur 357, Col. CENTRO, Zamora, Michoacan de Ocampo, Mexico
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/24/2017 | 61WBY04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ANA MARIA RUIZ GONZALEZ's FDA import refusal history?
ANA MARIA RUIZ GONZALEZ (FEI: 3013473131) has 1 FDA import refusal record(s) in our database, spanning from 5/24/2017 to 5/24/2017.
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. ANA MARIA RUIZ GONZALEZ's FEI number is 3013473131.
What types of violations has ANA MARIA RUIZ GONZALEZ received?
ANA MARIA RUIZ GONZALEZ has been cited for 1 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 ANA MARIA RUIZ GONZALEZ come from?
All FDA import refusal data for ANA MARIA RUIZ 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.