OPTIMA NATURAL SRL
⚠️ Moderate Risk
FEI: 3027285030 • Vergiate, Varese • ITALY
FEI Number
3027285030
Location
Vergiate, Varese
Country
ITALYAddress
Via Sempione 124, , Vergiate, Varese, 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
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
NOCONTACT
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act because it appears to be a nonprescription drug that is misbranded within the meaning of Section 502(x) of the FD&C Act in that the product label fails to bear a domestic address or phone number through which the responsible person may receive a report of a serious adverse event with such drug.
Refusal History
Frequently Asked Questions
What is OPTIMA NATURAL SRL's FDA import refusal history?
OPTIMA NATURAL SRL (FEI: 3027285030) has 1 FDA import refusal record(s) in our database, spanning from 8/27/2024 to 8/27/2024.
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. OPTIMA NATURAL SRL's FEI number is 3027285030.
What types of violations has OPTIMA NATURAL SRL received?
OPTIMA NATURAL SRL 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 OPTIMA NATURAL SRL come from?
All FDA import refusal data for OPTIMA NATURAL 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.