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HTO Nevada Inc. dba Kirkman

⚠️ Moderate Risk

FEI: 3004268965 • Lake Oswego, OR • UNITED STATES

FEI

FEI Number

3004268965

📍

Location

Lake Oswego, OR

🇺🇸
🏢

Address

6400 Rosewood St, , Lake Oswego, OR, United States

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
7/19/2017
Latest Refusal
7/19/2017
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

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
7/19/2017
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is HTO Nevada Inc. dba Kirkman's FDA import refusal history?

HTO Nevada Inc. dba Kirkman (FEI: 3004268965) has 1 FDA import refusal record(s) in our database, spanning from 7/19/2017 to 7/19/2017.

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. HTO Nevada Inc. dba Kirkman's FEI number is 3004268965.

What types of violations has HTO Nevada Inc. dba Kirkman received?

HTO Nevada Inc. dba Kirkman 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 HTO Nevada Inc. dba Kirkman come from?

All FDA import refusal data for HTO Nevada Inc. dba Kirkman 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.