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Cooperativa De Agua Potable Sto.Dgo

⚠️ Moderate Risk

FEI: 3005920600 • San Antoniosan Antonio • CHILE

FEI

FEI Number

3005920600

📍

Location

San Antoniosan Antonio

🇨🇱

Country

CHILE
🏢

Address

Griselda N*21, , San Antoniosan Antonio, , Chile

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
10/23/2006
Latest Refusal
10/23/2006
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

751×

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
10/23/2006
62OCB20CAPTOPRIL (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Cooperativa De Agua Potable Sto.Dgo's FDA import refusal history?

Cooperativa De Agua Potable Sto.Dgo (FEI: 3005920600) has 1 FDA import refusal record(s) in our database, spanning from 10/23/2006 to 10/23/2006.

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. Cooperativa De Agua Potable Sto.Dgo's FEI number is 3005920600.

What types of violations has Cooperativa De Agua Potable Sto.Dgo received?

Cooperativa De Agua Potable Sto.Dgo 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 Cooperativa De Agua Potable Sto.Dgo come from?

All FDA import refusal data for Cooperativa De Agua Potable Sto.Dgo 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.