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Pakmail Cholula

⚠️ Moderate Risk

FEI: 3006620576 • Pue • MEXICO

FEI

FEI Number

3006620576

📍

Location

Pue

🇲🇽

Country

MEXICO
🏢

Address

Av. Hidalgo # 716 Loc 7col. Centro, , Puebla,Puepuebla,Pue, , Mexico

Moderate Risk

FDA Import Risk Assessment

43.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
3/6/2008
Latest Refusal
3/6/2008
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

752×

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
3/6/2008
62YCA07MELOXICAM (ANTI-INFLAMMATORY, PART II)
75UNAPPROVED
Cincinnati District Office (CIN-DO)
3/6/2008
61WCA47KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Pakmail Cholula's FDA import refusal history?

Pakmail Cholula (FEI: 3006620576) has 2 FDA import refusal record(s) in our database, spanning from 3/6/2008 to 3/6/2008.

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. Pakmail Cholula's FEI number is 3006620576.

What types of violations has Pakmail Cholula received?

Pakmail Cholula 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 Pakmail Cholula come from?

All FDA import refusal data for Pakmail Cholula 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.