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Lab. De Med. Naturales San Juan

⚠️ Moderate Risk

FEI: 3003881364 • Culiacan, Sinaloa • MEXICO

FEI

FEI Number

3003881364

📍

Location

Culiacan, Sinaloa

🇲🇽

Country

MEXICO
🏢

Address

Avenida Reforma 1858, Col. SALVADOR ALVARADO, Culiacan, Sinaloa, Mexico

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
2/13/2006
Latest Refusal
2/13/2006
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

4721×

NO ENGLISH

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

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
2/13/2006
65BBL99MUCOLYTIC N.E.C.
472NO ENGLISH
75UNAPPROVED
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Lab. De Med. Naturales San Juan's FDA import refusal history?

Lab. De Med. Naturales San Juan (FEI: 3003881364) has 1 FDA import refusal record(s) in our database, spanning from 2/13/2006 to 2/13/2006.

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. Lab. De Med. Naturales San Juan's FEI number is 3003881364.

What types of violations has Lab. De Med. Naturales San Juan received?

Lab. De Med. Naturales San Juan 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 Lab. De Med. Naturales San Juan come from?

All FDA import refusal data for Lab. De Med. Naturales San Juan 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.