ImportRefusal LogoImportRefusal

JUANA FERRER TAMAYO

⚠️ Moderate Risk

FEI: 3023571351 • Celaya • MEXICO

FEI

FEI Number

3023571351

📍

Location

Celaya

🇲🇽

Country

MEXICO
🏢

Address

Lazaro Cardenas # 200 F, , Celaya, , Mexico

Moderate Risk

FDA Import Risk Assessment

34.9
LowModerateHighCritical

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

Statistics

5
Total Refusals
2
Unique Violations
11/9/2022
Latest Refusal
11/9/2022
Earliest Refusal

Score Breakdown

Violation Severity
42.0×40%
Refusal Volume
28.8×30%
Recency
22.0×20%
Frequency
50.0×10%
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

32604×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(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
11/9/2022
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
3260NO ENGLISH
Division of Southeast Imports (DSEI)
11/9/2022
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
3260NO ENGLISH
Division of Southeast Imports (DSEI)
11/9/2022
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
3260NO ENGLISH
Division of Southeast Imports (DSEI)
11/9/2022
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
3260NO ENGLISH
Division of Southeast Imports (DSEI)
11/9/2022
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is JUANA FERRER TAMAYO's FDA import refusal history?

JUANA FERRER TAMAYO (FEI: 3023571351) has 5 FDA import refusal record(s) in our database, spanning from 11/9/2022 to 11/9/2022.

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. JUANA FERRER TAMAYO's FEI number is 3023571351.

What types of violations has JUANA FERRER TAMAYO received?

JUANA FERRER TAMAYO 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 JUANA FERRER TAMAYO come from?

All FDA import refusal data for JUANA FERRER TAMAYO 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.