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RICHMAR ULTRATOUCH

⚠️ Moderate Risk

FEI: 3027690713 • Saint Louis, MO • UNITED STATES

FEI

FEI Number

3027690713

📍

Location

Saint Louis, MO

🇺🇸
🏢

Address

7777 Bonhomme Ave # Su, , Saint Louis, MO, United States

Moderate Risk

FDA Import Risk Assessment

34.9
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
9/12/2023
Latest Refusal
9/12/2023
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
52.8×20%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
9/12/2023
84QLKSTIMULATOR, NEUROMUSCULAR, LOWER BACK MUSCLES, TOTALLY IMPLANTED FOR PAIN RELIEF
118NOT LISTED
3280FRNMFGREG
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is RICHMAR ULTRATOUCH's FDA import refusal history?

RICHMAR ULTRATOUCH (FEI: 3027690713) has 1 FDA import refusal record(s) in our database, spanning from 9/12/2023 to 9/12/2023.

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. RICHMAR ULTRATOUCH's FEI number is 3027690713.

What types of violations has RICHMAR ULTRATOUCH received?

RICHMAR ULTRATOUCH 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 RICHMAR ULTRATOUCH come from?

All FDA import refusal data for RICHMAR ULTRATOUCH 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.