BIOFARM Ltd.
⚠️ High Risk
FEI: 3004678368 • Poznan, PL-WP • POLAND
FEI Number
3004678368
Location
Poznan, PL-WP
Country
POLANDAddress
ul. Walbrzyska 13, , Poznan, PL-WP, Poland
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
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
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
Frequently Asked Questions
What is BIOFARM Ltd.'s FDA import refusal history?
BIOFARM Ltd. (FEI: 3004678368) has 2 FDA import refusal record(s) in our database, spanning from 11/21/2025 to 11/21/2025.
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. BIOFARM Ltd.'s FEI number is 3004678368.
What types of violations has BIOFARM Ltd. received?
BIOFARM Ltd. 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 BIOFARM Ltd. come from?
All FDA import refusal data for BIOFARM Ltd. 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.