ImportRefusal LogoImportRefusal

Apartado

Low Risk

FEI: 3004121922 • Castanheira • PORTUGAL

FEI

FEI Number

3004121922

📍

Location

Castanheira

🇵🇹

Country

PORTUGAL
🏢

Address

Unknown Street, , Castanheira, , Portugal

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
3
Unique Violations
9/15/2003
Latest Refusal
9/15/2003
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

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.

28801×

RXCOMPOUND

the labeling fails to bear, at a minimum, the symbol "Rx only."

3361×

INCONSPICU

Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

Refusal History

DateProductViolationsDivision
9/15/2003
56ECS80TETRACYCLINE (TETRACYCLINES)
16DIRECTIONS
2880RXCOMPOUND
336INCONSPICU
Detroit District Office (DET-DO)

Frequently Asked Questions

What is Apartado's FDA import refusal history?

Apartado (FEI: 3004121922) has 1 FDA import refusal record(s) in our database, spanning from 9/15/2003 to 9/15/2003.

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. Apartado's FEI number is 3004121922.

What types of violations has Apartado received?

Apartado has been cited for 3 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 Apartado come from?

All FDA import refusal data for Apartado 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.