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PHARMACEUTICAL HELATH CORPORATION SAS

⚠️ Moderate Risk

FEI: 3029806525 • Medellin, Antioquia • COLOMBIA

FEI

FEI Number

3029806525

📍

Location

Medellin, Antioquia

🇨🇴

Country

COLOMBIA
🏢

Address

Barrio Colombia, Calle 29 44 174, Medellin, Antioquia, Colombia

Moderate Risk

FDA Import Risk Assessment

37.8
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
6/3/2024
Latest Refusal
6/3/2024
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
67.5×20%
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

2601×

FALSE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.

Refusal History

DateProductViolationsDivision
6/3/2024
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
260FALSE
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is PHARMACEUTICAL HELATH CORPORATION SAS's FDA import refusal history?

PHARMACEUTICAL HELATH CORPORATION SAS (FEI: 3029806525) has 1 FDA import refusal record(s) in our database, spanning from 6/3/2024 to 6/3/2024.

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. PHARMACEUTICAL HELATH CORPORATION SAS's FEI number is 3029806525.

What types of violations has PHARMACEUTICAL HELATH CORPORATION SAS received?

PHARMACEUTICAL HELATH CORPORATION SAS 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 PHARMACEUTICAL HELATH CORPORATION SAS come from?

All FDA import refusal data for PHARMACEUTICAL HELATH CORPORATION SAS 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.