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SALUS NUTRA INC

⚠️ Moderate Risk

FEI: 3015481822 • Jinye Xi An • CHINA

FEI

FEI Number

3015481822

📍

Location

Jinye Xi An

🇨🇳

Country

CHINA
🏢

Address

Rm 7-1306 Shine City Bl, , Jinye Xi An, , China

Moderate Risk

FDA Import Risk Assessment

25.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
2/16/2021
Latest Refusal
2/16/2021
Earliest Refusal

Score Breakdown

Violation Severity
53.3×40%
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

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).

3331×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

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
2/16/2021
66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
333LACKS FIRM
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SALUS NUTRA INC's FDA import refusal history?

SALUS NUTRA INC (FEI: 3015481822) has 1 FDA import refusal record(s) in our database, spanning from 2/16/2021 to 2/16/2021.

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. SALUS NUTRA INC's FEI number is 3015481822.

What types of violations has SALUS NUTRA INC received?

SALUS NUTRA INC has been cited for 3 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 SALUS NUTRA INC come from?

All FDA import refusal data for SALUS NUTRA INC 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.