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Industrias Quimicas Y Farmaceuticas, C. Por A.

⚠️ Moderate Risk

FEI: 3001374840 • Santo Domingo • DOMINICAN REPUBLIC

FEI

FEI Number

3001374840

📍

Location

Santo Domingo

🇩🇴
🏢

Address

Carr. Manoguayabo Km. 2, , Santo Domingo, , Dominican Republic

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
1/25/2002
Latest Refusal
1/25/2002
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

721×

NEW VET DR

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.

Refusal History

DateProductViolationsDivision
1/25/2002
67B31LEVAMISOLE CATEGORY II, TYPE A MEDICATED ARTICLE
72NEW VET DR
San Juan District Office (SJN-DO)

Frequently Asked Questions

What is Industrias Quimicas Y Farmaceuticas, C. Por A.'s FDA import refusal history?

Industrias Quimicas Y Farmaceuticas, C. Por A. (FEI: 3001374840) has 1 FDA import refusal record(s) in our database, spanning from 1/25/2002 to 1/25/2002.

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. Industrias Quimicas Y Farmaceuticas, C. Por A.'s FEI number is 3001374840.

What types of violations has Industrias Quimicas Y Farmaceuticas, C. Por A. received?

Industrias Quimicas Y Farmaceuticas, C. Por 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 Industrias Quimicas Y Farmaceuticas, C. Por A. come from?

All FDA import refusal data for Industrias Quimicas Y Farmaceuticas, C. Por 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.