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PSICOFARMA SA DE CV PARQUE

⚠️ High Risk

FEI: 3016682510 • Toluca De Lerdo • MEXICO

FEI

FEI Number

3016682510

📍

Location

Toluca De Lerdo

🇲🇽

Country

MEXICO
🏢

Address

Industrial 50030 Isidro, , Toluca De Lerdo, , Mexico

High Risk

FDA Import Risk Assessment

61.0
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
11/6/2025
Latest Refusal
11/1/2021
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
96.0×20%
Frequency
5.0×10%
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

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
11/6/2025
66BAY19METHYLPHENIDATE HCL (STIMULANT)
75UNAPPROVED
Division of Southeast Imports (DSEI)
11/1/2021
66NCY03QUETIAPINE FUMARATE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is PSICOFARMA SA DE CV PARQUE's FDA import refusal history?

PSICOFARMA SA DE CV PARQUE (FEI: 3016682510) has 2 FDA import refusal record(s) in our database, spanning from 11/1/2021 to 11/6/2025.

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. PSICOFARMA SA DE CV PARQUE's FEI number is 3016682510.

What types of violations has PSICOFARMA SA DE CV PARQUE received?

PSICOFARMA SA DE CV PARQUE 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 PSICOFARMA SA DE CV PARQUE come from?

All FDA import refusal data for PSICOFARMA SA DE CV PARQUE 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.