ImportRefusal LogoImportRefusal

Satimed Uab

⚠️ Moderate Risk

FEI: 3012205592 • Vilnius, Vilniaus • LITHUANIA

FEI

FEI Number

3012205592

📍

Location

Vilnius, Vilniaus

🇱🇹

Country

LITHUANIA
🏢

Address

Meteliu G 4, , Vilnius, Vilniaus, Lithuania

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
8/30/2016
Latest Refusal
8/30/2016
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

21201×

UNSFDIETSP

The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.

38641×

NCONTACT

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.

Refusal History

DateProductViolationsDivision
8/30/2016
54HAL99FATS AND LIPID SUBSTANCES, N.E.C.
2120UNSFDIETSP
3864NCONTACT
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Satimed Uab's FDA import refusal history?

Satimed Uab (FEI: 3012205592) has 1 FDA import refusal record(s) in our database, spanning from 8/30/2016 to 8/30/2016.

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. Satimed Uab's FEI number is 3012205592.

What types of violations has Satimed Uab received?

Satimed Uab 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 Satimed Uab come from?

All FDA import refusal data for Satimed Uab 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.