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MEXIALOE LABORATORIOS S.A. DE C.V.

⚠️ Moderate Risk

FEI: 3006549242 • China, Campeche • MEXICO

FEI

FEI Number

3006549242

📍

Location

China, Campeche

🇲🇽

Country

MEXICO
🏢

Address

Carretera China Pocyaxun Km 4, Campeche, China, Campeche, Mexico

Moderate Risk

FDA Import Risk Assessment

43.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
11/27/2006
Latest Refusal
11/27/2006
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

834×

NO PROCESS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.

Refusal History

DateProductViolationsDivision
11/27/2006
29CGO99NONALCOHOLIC BEVERAGES, N.E.C.
83NO PROCESS
Southwest Import District Office (SWI-DO)
11/27/2006
29CGO99NONALCOHOLIC BEVERAGES, N.E.C.
83NO PROCESS
Southwest Import District Office (SWI-DO)
11/27/2006
29CGO99NONALCOHOLIC BEVERAGES, N.E.C.
83NO PROCESS
Southwest Import District Office (SWI-DO)
11/27/2006
29CGO99NONALCOHOLIC BEVERAGES, N.E.C.
83NO PROCESS
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is MEXIALOE LABORATORIOS S.A. DE C.V.'s FDA import refusal history?

MEXIALOE LABORATORIOS S.A. DE C.V. (FEI: 3006549242) has 4 FDA import refusal record(s) in our database, spanning from 11/27/2006 to 11/27/2006.

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. MEXIALOE LABORATORIOS S.A. DE C.V.'s FEI number is 3006549242.

What types of violations has MEXIALOE LABORATORIOS S.A. DE C.V. received?

MEXIALOE LABORATORIOS S.A. DE C.V. has been cited for 1 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 MEXIALOE LABORATORIOS S.A. DE C.V. come from?

All FDA import refusal data for MEXIALOE LABORATORIOS 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.