ImportRefusal LogoImportRefusal

CARPE DIEM CW SL

⚠️ Moderate Risk

FEI: 3020217125 • Mostoles, Madrid • SPAIN

FEI

FEI Number

3020217125

📍

Location

Mostoles, Madrid

🇪🇸

Country

SPAIN
🏢

Address

Calle De Juan Ramon Jimenez 8, , Mostoles, Madrid, Spain

Moderate Risk

FDA Import Risk Assessment

37.1
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
12/1/2021
Latest Refusal
12/1/2021
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
11.2×30%
Recency
3.7×20%
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

2371×

NO PMA

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).

Refusal History

DateProductViolationsDivision
12/1/2021
66YDP99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
237NO PMA
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is CARPE DIEM CW SL's FDA import refusal history?

CARPE DIEM CW SL (FEI: 3020217125) has 1 FDA import refusal record(s) in our database, spanning from 12/1/2021 to 12/1/2021.

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. CARPE DIEM CW SL's FEI number is 3020217125.

What types of violations has CARPE DIEM CW SL received?

CARPE DIEM CW SL 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 CARPE DIEM CW SL come from?

All FDA import refusal data for CARPE DIEM CW SL 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.