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Nery Insuasty Salas

⚠️ Moderate Risk

FEI: 3012058108 • Pasto, Narino • COLOMBIA

FEI

FEI Number

3012058108

📍

Location

Pasto, Narino

🇨🇴

Country

COLOMBIA
🏢

Address

Carrera 25 19 45 Of 304, , Pasto, Narino, Colombia

Moderate Risk

FDA Import Risk Assessment

45.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
2/9/2016
Latest Refusal
2/9/2016
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

753×

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
2/9/2016
66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
2/9/2016
56EYY20DOXYCYCLINE (TETRACYCLINES)
75UNAPPROVED
Cincinnati District Office (CIN-DO)
2/9/2016
56CYY27CEPHALEXIN (CEPHALOSPORINS)
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Nery Insuasty Salas's FDA import refusal history?

Nery Insuasty Salas (FEI: 3012058108) has 3 FDA import refusal record(s) in our database, spanning from 2/9/2016 to 2/9/2016.

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. Nery Insuasty Salas's FEI number is 3012058108.

What types of violations has Nery Insuasty Salas received?

Nery Insuasty Salas 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 Nery Insuasty Salas come from?

All FDA import refusal data for Nery Insuasty Salas 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.