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SIMEOFORIDIS AGAPIOS - GRAMMOU GI

⚠️ Moderate Risk

FEI: 3011910957 • Kerasona (Kastorias), Kastorias • GREECE

FEI

FEI Number

3011910957

📍

Location

Kerasona (Kastorias), Kastorias

🇬🇷

Country

GREECE
🏢

Address

Pentavrisso Kastoria, , Kerasona (Kastorias), Kastorias, Greece

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
1/14/2016
Latest Refusal
1/14/2016
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

751×

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
1/14/2016
66VAY99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
75UNAPPROVED
New York District Office (NYK-DO)

Frequently Asked Questions

What is SIMEOFORIDIS AGAPIOS - GRAMMOU GI's FDA import refusal history?

SIMEOFORIDIS AGAPIOS - GRAMMOU GI (FEI: 3011910957) has 1 FDA import refusal record(s) in our database, spanning from 1/14/2016 to 1/14/2016.

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. SIMEOFORIDIS AGAPIOS - GRAMMOU GI's FEI number is 3011910957.

What types of violations has SIMEOFORIDIS AGAPIOS - GRAMMOU GI received?

SIMEOFORIDIS AGAPIOS - GRAMMOU GI 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 SIMEOFORIDIS AGAPIOS - GRAMMOU GI come from?

All FDA import refusal data for SIMEOFORIDIS AGAPIOS - GRAMMOU GI 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.