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Pharma Medico ApS

✅ Low Risk

FEI: 2000031304 • Aarhus C, Midtjylland • DENMARK

FEI

FEI Number

2000031304

📍

Location

Aarhus C, Midtjylland

🇩🇰

Country

DENMARK
🏢

Address

Graven 25, , Aarhus C, Midtjylland, Denmark

Low Risk

FDA Import Risk Assessment

20.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
1/18/2017
Latest Refusal
1/18/2017
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
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

38641×

NCONTACT

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.

Refusal History

DateProductViolationsDivision
1/18/2017
54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
3864NCONTACT
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Pharma Medico ApS's FDA import refusal history?

Pharma Medico ApS (FEI: 2000031304) has 1 FDA import refusal record(s) in our database, spanning from 1/18/2017 to 1/18/2017.

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. Pharma Medico ApS's FEI number is 2000031304.

What types of violations has Pharma Medico ApS received?

Pharma Medico ApS 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 Pharma Medico ApS come from?

All FDA import refusal data for Pharma Medico ApS 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.