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Riger Naturals Sa

✅ Low Risk

FEI: 3012345682 • Toluca, Mexico • MEXICO

FEI

FEI Number

3012345682

📍

Location

Toluca, Mexico

🇲🇽

Country

MEXICO
🏢

Address

Col Moderna De La Cruz, , Toluca, Mexico, Mexico

Low Risk

FDA Import Risk Assessment

22.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
5
Unique Violations
7/25/2016
Latest Refusal
7/25/2016
Earliest Refusal

Score Breakdown

Violation Severity
46.0×40%
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

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.

3351×

LACKS N/C

The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.

4721×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

4831×

DRUG NAME

The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.

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
7/25/2016
62GBY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY)
333LACKS FIRM
335LACKS N/C
472NO ENGLISH
483DRUG NAME
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Riger Naturals Sa's FDA import refusal history?

Riger Naturals Sa (FEI: 3012345682) has 1 FDA import refusal record(s) in our database, spanning from 7/25/2016 to 7/25/2016.

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. Riger Naturals Sa's FEI number is 3012345682.

What types of violations has Riger Naturals Sa received?

Riger Naturals Sa has been cited for 5 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 Riger Naturals Sa come from?

All FDA import refusal data for Riger Naturals Sa 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.