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St Katherine Drexer

Low Risk

FEI: 3003484199 • New Orleans, LA • UNITED STATES

FEI

FEI Number

3003484199

📍

Location

New Orleans, LA

🇺🇸
🏢

Address

7238 Dixon St, , New Orleans, LA, United States

Low Risk

FDA Import Risk Assessment

21.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

2
Total Refusals
2
Unique Violations
11/30/2001
Latest Refusal
11/30/2001
Earliest Refusal

Score Breakdown

Violation Severity
35.0×40%
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

23001×

DIETARYLBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.

3241×

NO ENGLISH

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).

Refusal History

DateProductViolationsDivision
11/30/2001
54AYY99VITAMIN, N.E.C.
2300DIETARYLBL
New Orleans District Office (NOL-DO)
11/30/2001
54AYY99VITAMIN, N.E.C.
324NO ENGLISH
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is St Katherine Drexer's FDA import refusal history?

St Katherine Drexer (FEI: 3003484199) has 2 FDA import refusal record(s) in our database, spanning from 11/30/2001 to 11/30/2001.

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. St Katherine Drexer's FEI number is 3003484199.

What types of violations has St Katherine Drexer received?

St Katherine Drexer has been cited for 2 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 St Katherine Drexer come from?

All FDA import refusal data for St Katherine Drexer 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.