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Linea S.R.L

⚠️ Moderate Risk

FEI: 3008615949 • Santo Domingosanto Domingo • DOMINICAN REPUBLIC

FEI

FEI Number

3008615949

📍

Location

Santo Domingosanto Domingo

🇩🇴
🏢

Address

Av. Cesar Nicolas Penson No. 57gazcue, , Santo Domingosanto Domingo, , Dominican Republic

Moderate Risk

FDA Import Risk Assessment

43.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
12/21/2010
Latest Refusal
12/21/2010
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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
12/21/2010
62OCY19CANDESARTAN CILEXETIL (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
Cincinnati District Office (CIN-DO)
12/21/2010
62OCY14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II)
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Linea S.R.L's FDA import refusal history?

Linea S.R.L (FEI: 3008615949) has 2 FDA import refusal record(s) in our database, spanning from 12/21/2010 to 12/21/2010.

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. Linea S.R.L's FEI number is 3008615949.

What types of violations has Linea S.R.L received?

Linea S.R.L 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 Linea S.R.L come from?

All FDA import refusal data for Linea S.R.L 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.