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SHELO NABEL

⚠️ High Risk

FEI: 3020655372 • Jalisco • MEXICO

FEI

FEI Number

3020655372

📍

Location

Jalisco

🇲🇽

Country

MEXICO
🏢

Address

Av. Paseo Royal Country, , Jalisco, , Mexico

High Risk

FDA Import Risk Assessment

56.6
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

7
Total Refusals
1
Unique Violations
8/23/2022
Latest Refusal
11/5/2021
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
33.5×30%
Recency
17.9×20%
Frequency
70.0×10%
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

757×

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
8/23/2022
54YFY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
8/23/2022
62FDY99ANTI-INFECTIVE, TOPICAL N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
8/23/2022
54YFY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
8/23/2022
62FDY99ANTI-INFECTIVE, TOPICAL N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
8/23/2022
62FDY99ANTI-INFECTIVE, TOPICAL N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
11/5/2021
65RDY99REPLENISHER N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
11/5/2021
65RDY99REPLENISHER N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SHELO NABEL's FDA import refusal history?

SHELO NABEL (FEI: 3020655372) has 7 FDA import refusal record(s) in our database, spanning from 11/5/2021 to 8/23/2022.

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. SHELO NABEL's FEI number is 3020655372.

What types of violations has SHELO NABEL received?

SHELO NABEL 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 SHELO NABEL come from?

All FDA import refusal data for SHELO NABEL 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.