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Buzon Purepecha Sa De Cv

⚠️ Moderate Risk

FEI: 3012125974 • Cuautla, Morelos • MEXICO

FEI

FEI Number

3012125974

📍

Location

Cuautla, Morelos

🇲🇽

Country

MEXICO
🏢

Address

Calle Conspiradores 6 Loc. B, Col. CENTRO, Cuautla, Morelos, Mexico

Moderate Risk

FDA Import Risk Assessment

45.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
3/10/2016
Latest Refusal
3/10/2016
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

753×

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
3/10/2016
54FCA58SAW PALMETTO (HERBAL & BOTANICALS, NOT TEAS)
75UNAPPROVED
Division of Southeast Imports (DSEI)
3/10/2016
56YDA99ANTIBIOTIC N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
3/10/2016
61WAA45FLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Buzon Purepecha Sa De Cv's FDA import refusal history?

Buzon Purepecha Sa De Cv (FEI: 3012125974) has 3 FDA import refusal record(s) in our database, spanning from 3/10/2016 to 3/10/2016.

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. Buzon Purepecha Sa De Cv's FEI number is 3012125974.

What types of violations has Buzon Purepecha Sa De Cv received?

Buzon Purepecha Sa De Cv 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 Buzon Purepecha Sa De Cv come from?

All FDA import refusal data for Buzon Purepecha Sa De Cv 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.