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Postnet Montana

⚠️ Moderate Risk

FEI: 3007175130 • Pretoria • SOUTH AFRICA

FEI

FEI Number

3007175130

📍

Location

Pretoria

🇿🇦
🏢

Address

Shop 13 Montnana Corner Centre, , Pretoria, , South Africa

Moderate Risk

FDA Import Risk Assessment

42.4
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
10/18/2010
Latest Refusal
11/21/2008
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
10.5×10%
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
10/18/2010
61PIY99ANTI-DIABETIC N.E.C.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
11/21/2008
65VCA56ZOLPIDEM TARTRATE (SEDATIVE)
75UNAPPROVED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Postnet Montana's FDA import refusal history?

Postnet Montana (FEI: 3007175130) has 2 FDA import refusal record(s) in our database, spanning from 11/21/2008 to 10/18/2010.

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. Postnet Montana's FEI number is 3007175130.

What types of violations has Postnet Montana received?

Postnet Montana 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 Postnet Montana come from?

All FDA import refusal data for Postnet Montana 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.