ImportRefusal LogoImportRefusal

Paiquiere Ind E Com Ltda

⚠️ Moderate Risk

FEI: 3004189092 • Curitiba, Parana • BRAZIL

FEI

FEI Number

3004189092

📍

Location

Curitiba, Parana

🇧🇷

Country

BRAZIL
🏢

Address

Rua Primo Lourenco Tosin 127, , Curitiba, Parana, Brazil

Moderate Risk

FDA Import Risk Assessment

33.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
2/14/2007
Latest Refusal
7/28/2006
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

4711×

CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.

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
2/14/2007
53LF08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
7/28/2006
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Paiquiere Ind E Com Ltda's FDA import refusal history?

Paiquiere Ind E Com Ltda (FEI: 3004189092) has 2 FDA import refusal record(s) in our database, spanning from 7/28/2006 to 2/14/2007.

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. Paiquiere Ind E Com Ltda's FEI number is 3004189092.

What types of violations has Paiquiere Ind E Com Ltda received?

Paiquiere Ind E Com Ltda 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 Paiquiere Ind E Com Ltda come from?

All FDA import refusal data for Paiquiere Ind E Com Ltda 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.