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Novartis Chile (Gcia. Gral.)

⚠️ Moderate Risk

FEI: 3009051511 • Santiagosantiago • CHILE

FEI

FEI Number

3009051511

📍

Location

Santiagosantiago

🇨🇱

Country

CHILE
🏢

Address

Rosario Norte 615 Piso 9?U?Oa, , Santiagosantiago, , Chile

Moderate Risk

FDA Import Risk Assessment

30.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
9/27/2011
Latest Refusal
9/27/2011
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

2371×

NO PMA

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).

Refusal History

DateProductViolationsDivision
9/27/2011
86LPMLENSES, SOFT CONTACT, EXTENDED WEAR
118NOT LISTED
237NO PMA
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Novartis Chile (Gcia. Gral.)'s FDA import refusal history?

Novartis Chile (Gcia. Gral.) (FEI: 3009051511) has 1 FDA import refusal record(s) in our database, spanning from 9/27/2011 to 9/27/2011.

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. Novartis Chile (Gcia. Gral.)'s FEI number is 3009051511.

What types of violations has Novartis Chile (Gcia. Gral.) received?

Novartis Chile (Gcia. Gral.) has been cited for 2 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 Novartis Chile (Gcia. Gral.) come from?

All FDA import refusal data for Novartis Chile (Gcia. Gral.) 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.