Fisiopharma Srl
⚠️ Moderate Risk
FEI: 3006435023 • Palomonte, Salerno • ITALY
FEI Number
3006435023
Location
Palomonte, Salerno
Country
ITALYAddress
Zona Industriale, Localita San Pietro, Palomonte, Salerno, Italy
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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 Fisiopharma Srl's FDA import refusal history?
Fisiopharma Srl (FEI: 3006435023) has 3 FDA import refusal record(s) in our database, spanning from 8/29/2018 to 3/19/2021.
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. Fisiopharma Srl's FEI number is 3006435023.
What types of violations has Fisiopharma Srl received?
Fisiopharma Srl 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 Fisiopharma Srl come from?
All FDA import refusal data for Fisiopharma Srl 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.