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Petrona Juarez Ort

✅ Low Risk

FEI: 3004195251 • Quiche, El Quiche • GUATEMALA

FEI

FEI Number

3004195251

📍

Location

Quiche, El Quiche

🇬🇹

Country

GUATEMALA
🏢

Address

Quiacoj, , Quiche, El Quiche, Guatemala

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
2
Unique Violations
2/3/2004
Latest Refusal
2/3/2004
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

3311×

DR QUALITC

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.

4721×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

Refusal History

DateProductViolationsDivision
2/3/2004
60LCC01ACETAMINOPHEN (ANALGESIC)
331DR QUALITC
472NO ENGLISH
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Petrona Juarez Ort's FDA import refusal history?

Petrona Juarez Ort (FEI: 3004195251) has 1 FDA import refusal record(s) in our database, spanning from 2/3/2004 to 2/3/2004.

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. Petrona Juarez Ort's FEI number is 3004195251.

What types of violations has Petrona Juarez Ort received?

Petrona Juarez Ort 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 Petrona Juarez Ort come from?

All FDA import refusal data for Petrona Juarez Ort 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.