ImportRefusal LogoImportRefusal

LABIALFARMA - LAB PROD FARM E NUTRA

⚠️ Moderate Risk

FEI: 3021955831 • Viseu, Viseu • PORTUGAL

FEI

FEI Number

3021955831

📍

Location

Viseu, Viseu

🇵🇹

Country

PORTUGAL
🏢

Address

Edificio Labialfarma 1, Rua Felgueira; Oliveira De Barreiros, Viseu, Viseu, Portugal

Moderate Risk

FDA Import Risk Assessment

42.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
1/16/2024
Latest Refusal
1/16/2024
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
Refusal Volume
11.2×30%
Recency
59.8×20%
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

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

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
1/16/2024
54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
473LABELING
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is LABIALFARMA - LAB PROD FARM E NUTRA's FDA import refusal history?

LABIALFARMA - LAB PROD FARM E NUTRA (FEI: 3021955831) has 1 FDA import refusal record(s) in our database, spanning from 1/16/2024 to 1/16/2024.

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. LABIALFARMA - LAB PROD FARM E NUTRA's FEI number is 3021955831.

What types of violations has LABIALFARMA - LAB PROD FARM E NUTRA received?

LABIALFARMA - LAB PROD FARM E NUTRA 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 LABIALFARMA - LAB PROD FARM E NUTRA come from?

All FDA import refusal data for LABIALFARMA - LAB PROD FARM E NUTRA 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.