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NEOLPHARMA S.A.

⚠️ High Risk

FEI: 3014114751 • Ciudad De Mexico, Ciudad de Mexico • MEXICO

FEI

FEI Number

3014114751

📍

Location

Ciudad De Mexico, Ciudad de Mexico

🇲🇽

Country

MEXICO
🏢

Address

Calle Boulevard De Los Ff. Cc. No. 277, Col. Industrial Vallejo, Azcapotzalco, Ciudad De Mexico, Ciudad de Mexico, Mexico

High Risk

FDA Import Risk Assessment

61.6
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

2
Total Refusals
1
Unique Violations
12/22/2025
Latest Refusal
4/7/2022
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
98.9×20%
Frequency
5.4×10%
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

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
12/22/2025
60LCK21DIPYRONE (ANALGESIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)
4/7/2022
66VCA99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is NEOLPHARMA S.A.'s FDA import refusal history?

NEOLPHARMA S.A. (FEI: 3014114751) has 2 FDA import refusal record(s) in our database, spanning from 4/7/2022 to 12/22/2025.

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. NEOLPHARMA S.A.'s FEI number is 3014114751.

What types of violations has NEOLPHARMA S.A. received?

NEOLPHARMA S.A. 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 NEOLPHARMA S.A. come from?

All FDA import refusal data for NEOLPHARMA S.A. 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.