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Remitente Laboratorios Ordesa S.L.

⚠️ Moderate Risk

FEI: 3010171863 • Barcelonabarcelona • SPAIN

FEI

FEI Number

3010171863

📍

Location

Barcelonabarcelona

🇪🇸

Country

SPAIN
🏢

Address

C/Osca, 18-20 Sant Boi De Llobregat, , Barcelonabarcelona, , Spain

Moderate Risk

FDA Import Risk Assessment

44.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
2/16/2023
Latest Refusal
2/16/2023
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
11.2×30%
Recency
42.0×20%
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

21601×

LACK NOTIF

Adulterated, 801(a)(3), lack of documentation establishing that the infant formula meets all notification conditions required by 412(c) or 412(d), Prohibited Act, Section 301(s).

Refusal History

DateProductViolationsDivision
2/16/2023
40PYY01MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA
2160LACK NOTIF
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Remitente Laboratorios Ordesa S.L.'s FDA import refusal history?

Remitente Laboratorios Ordesa S.L. (FEI: 3010171863) has 1 FDA import refusal record(s) in our database, spanning from 2/16/2023 to 2/16/2023.

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. Remitente Laboratorios Ordesa S.L.'s FEI number is 3010171863.

What types of violations has Remitente Laboratorios Ordesa S.L. received?

Remitente Laboratorios Ordesa S.L. 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 Remitente Laboratorios Ordesa S.L. come from?

All FDA import refusal data for Remitente Laboratorios Ordesa S.L. 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.