ImportRefusal LogoImportRefusal

CASEN RECORDATI

⚠️ Moderate Risk

FEI: 3013609159 • Utebo, Zaragoza • SPAIN

FEI

FEI Number

3013609159

📍

Location

Utebo, Zaragoza

🇪🇸

Country

SPAIN
🏢

Address

Autovia de Logrono KM 1, , Utebo, Zaragoza, Spain

Moderate Risk

FDA Import Risk Assessment

43.8
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
8/8/2022
Latest Refusal
8/8/2022
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
17.4×20%
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

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
8/8/2022
65KAJ99PROSTAGLANDIN N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is CASEN RECORDATI's FDA import refusal history?

CASEN RECORDATI (FEI: 3013609159) has 1 FDA import refusal record(s) in our database, spanning from 8/8/2022 to 8/8/2022.

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. CASEN RECORDATI's FEI number is 3013609159.

What types of violations has CASEN RECORDATI received?

CASEN RECORDATI 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 CASEN RECORDATI come from?

All FDA import refusal data for CASEN RECORDATI 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.