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Laboratorio y Herboristeria Santa Margarita S/A

⚠️ Moderate Risk

FEI: 3006024386 • San Juan Bautista, Misiones • PARAGUAY

FEI

FEI Number

3006024386

📍

Location

San Juan Bautista, Misiones

🇵🇾

Country

PARAGUAY
🏢

Address

Ruta 1 Mcal Francisco Solano Lopes, Km 197 5, San Juan Bautista, Misiones, Paraguay

Moderate Risk

FDA Import Risk Assessment

42.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
6/2/2016
Latest Refusal
5/21/2014
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
9.8×10%
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
6/2/2016
54EAE99HERBALS & BOTANICAL TEAS, N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
5/21/2014
54EFT99HERBALS & BOTANICAL TEAS, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Laboratorio y Herboristeria Santa Margarita S/A's FDA import refusal history?

Laboratorio y Herboristeria Santa Margarita S/A (FEI: 3006024386) has 2 FDA import refusal record(s) in our database, spanning from 5/21/2014 to 6/2/2016.

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. Laboratorio y Herboristeria Santa Margarita S/A's FEI number is 3006024386.

What types of violations has Laboratorio y Herboristeria Santa Margarita S/A received?

Laboratorio y Herboristeria Santa Margarita S/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 Laboratorio y Herboristeria Santa Margarita S/A come from?

All FDA import refusal data for Laboratorio y Herboristeria Santa Margarita S/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.