ImportRefusal LogoImportRefusal

SolySal de Colima, S.P.R. de R.L

⚠️ Moderate Risk

FEI: 3009154078 • Cuauhtemoc, COL • MEXICO

FEI

FEI Number

3009154078

📍

Location

Cuauhtemoc, COL

🇲🇽

Country

MEXICO
🏢

Address

Adolfo Lopez Mateos # 40, Col. El Toreo, Cuauhtemoc, COL, Mexico

Moderate Risk

FDA Import Risk Assessment

35.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
10/8/2013
Latest Refusal
10/8/2013
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

2602×

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.

752×

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
10/8/2013
28SGH04SALT, SEA (TABLE SALT)
260FALSE
75UNAPPROVED
Southwest Import District Office (SWI-DO)
10/8/2013
28SGH04SALT, SEA (TABLE SALT)
260FALSE
75UNAPPROVED
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is SolySal de Colima, S.P.R. de R.L's FDA import refusal history?

SolySal de Colima, S.P.R. de R.L (FEI: 3009154078) has 2 FDA import refusal record(s) in our database, spanning from 10/8/2013 to 10/8/2013.

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. SolySal de Colima, S.P.R. de R.L's FEI number is 3009154078.

What types of violations has SolySal de Colima, S.P.R. de R.L received?

SolySal de Colima, S.P.R. de R.L 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 SolySal de Colima, S.P.R. de R.L come from?

All FDA import refusal data for SolySal de Colima, S.P.R. de R.L 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.