ImportRefusal LogoImportRefusal

Red Pharma Laboratories Polska Spolka Akcyjna

⚠️ High Risk

FEI: 3013921732 • Lesznowola, Mazowieckie • POLAND

FEI

FEI Number

3013921732

📍

Location

Lesznowola, Mazowieckie

🇵🇱

Country

POLAND
🏢

Address

Ul. Sloneczna 116a, , Lesznowola, Mazowieckie, Poland

High Risk

FDA Import Risk Assessment

51.4
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

6
Total Refusals
1
Unique Violations
7/20/2018
Latest Refusal
7/20/2018
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
60.0×10%
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

756×

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
7/20/2018
54FCK99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
Division of Northern Border Imports (DNBI)
7/20/2018
54FCK99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
Division of Northern Border Imports (DNBI)
7/20/2018
54FCK99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
Division of Northern Border Imports (DNBI)
7/20/2018
54FCK99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
Division of Northern Border Imports (DNBI)
7/20/2018
54FCK99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
Division of Northern Border Imports (DNBI)
7/20/2018
54FCK99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is Red Pharma Laboratories Polska Spolka Akcyjna's FDA import refusal history?

Red Pharma Laboratories Polska Spolka Akcyjna (FEI: 3013921732) has 6 FDA import refusal record(s) in our database, spanning from 7/20/2018 to 7/20/2018.

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. Red Pharma Laboratories Polska Spolka Akcyjna's FEI number is 3013921732.

What types of violations has Red Pharma Laboratories Polska Spolka Akcyjna received?

Red Pharma Laboratories Polska Spolka Akcyjna 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 Red Pharma Laboratories Polska Spolka Akcyjna come from?

All FDA import refusal data for Red Pharma Laboratories Polska Spolka Akcyjna 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.