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WEIHE LABS S.A DE C.V

⚠️ Moderate Risk

FEI: 3008638410 • Cienega De Flores, NL • MEXICO

FEI

FEI Number

3008638410

📍

Location

Cienega De Flores, NL

🇲🇽

Country

MEXICO
🏢

Address

Gaviota 112, Fracc. Villas Campestres, Cienega De Flores, NL, Mexico

Moderate Risk

FDA Import Risk Assessment

28.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
4
Unique Violations
8/12/2016
Latest Refusal
8/12/2016
Earliest Refusal

Score Breakdown

Violation Severity
47.5×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

23003×

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.

2603×

FALSE

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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.

4733×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

4883×

HEALTH C

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.

Refusal History

DateProductViolationsDivision
8/12/2016
54ACR99VITAMIN, N.E.C.
2300DIETARYLBL
260FALSE
473LABELING
488HEALTH C
Division of Southwest Imports (DSWI)
8/12/2016
54ACR99VITAMIN, N.E.C.
2300DIETARYLBL
260FALSE
473LABELING
488HEALTH C
Division of Southwest Imports (DSWI)
8/12/2016
54ACR99VITAMIN, N.E.C.
2300DIETARYLBL
260FALSE
473LABELING
488HEALTH C
Division of Southwest Imports (DSWI)

Frequently Asked Questions

What is WEIHE LABS S.A DE C.V's FDA import refusal history?

WEIHE LABS S.A DE C.V (FEI: 3008638410) has 3 FDA import refusal record(s) in our database, spanning from 8/12/2016 to 8/12/2016.

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. WEIHE LABS S.A DE C.V's FEI number is 3008638410.

What types of violations has WEIHE LABS S.A DE C.V received?

WEIHE LABS S.A DE C.V has been cited for 4 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 WEIHE LABS S.A DE C.V come from?

All FDA import refusal data for WEIHE LABS S.A DE C.V 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.