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PHARMAINSA HONDURAS

⚠️ Moderate Risk

FEI: 3021464611 • Tegucigalpa, Francisco Morazan • HONDURAS

FEI

FEI Number

3021464611

📍

Location

Tegucigalpa, Francisco Morazan

🇭🇳

Country

HONDURAS
🏢

Address

5ta Avenida, , Tegucigalpa, Francisco Morazan, Honduras

Moderate Risk

FDA Import Risk Assessment

40.6
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
10/21/2022
Latest Refusal
10/21/2022
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
11.2×30%
Recency
21.5×20%
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

271×

DRUG GMPS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).

Refusal History

DateProductViolationsDivision
10/21/2022
61TAL02BUCLIZINE HCL (ANTI-EMETIC/NAUSEANT)
27DRUG GMPS
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is PHARMAINSA HONDURAS's FDA import refusal history?

PHARMAINSA HONDURAS (FEI: 3021464611) has 1 FDA import refusal record(s) in our database, spanning from 10/21/2022 to 10/21/2022.

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. PHARMAINSA HONDURAS's FEI number is 3021464611.

What types of violations has PHARMAINSA HONDURAS received?

PHARMAINSA HONDURAS 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 PHARMAINSA HONDURAS come from?

All FDA import refusal data for PHARMAINSA HONDURAS 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.