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PHARMACYS OF MEDICINES SA FARCOM

⚠️ Moderate Risk

FEI: 3012467136 • SECUNDARIA • ECUADOR

FEI

FEI Number

3012467136

📍

Location

SECUNDARIA

🇪🇨

Country

ECUADOR
🏢

Address

KM CINCO Y MEDIO AV DE, , SECUNDARIA, , Ecuador

Moderate Risk

FDA Import Risk Assessment

49.6
LowModerateHighCritical

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

Statistics

5
Total Refusals
1
Unique Violations
8/12/2016
Latest Refusal
8/12/2016
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
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

755×

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
8/12/2016
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)
8/12/2016
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)
8/12/2016
65LDL06CALAMINE (PROTECTANT)
75UNAPPROVED
New Orleans District Office (NOL-DO)
8/12/2016
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)
8/12/2016
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is PHARMACYS OF MEDICINES SA FARCOM's FDA import refusal history?

PHARMACYS OF MEDICINES SA FARCOM (FEI: 3012467136) has 5 FDA import refusal record(s) in our database, spanning from 8/12/2016 to 8/12/2016.

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. PHARMACYS OF MEDICINES SA FARCOM's FEI number is 3012467136.

What types of violations has PHARMACYS OF MEDICINES SA FARCOM received?

PHARMACYS OF MEDICINES SA FARCOM 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 PHARMACYS OF MEDICINES SA FARCOM come from?

All FDA import refusal data for PHARMACYS OF MEDICINES SA FARCOM 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.