Satimed Uab
⚠️ Moderate Risk
FEI: 3012327258 • Kovno, Kaunas County • LITHUANIA
FEI Number
3012327258
Location
Kovno, Kaunas County
Country
LITHUANIAAddress
Sukileliu Pr. 13, , Kovno, Kaunas County, Lithuania
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
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.
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).
DIETARYLBL
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(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/10/2019 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 5/10/2019 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 3/22/2018 | 54FYY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/16/2018 | 54FYL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Northern Border Imports (DNBI) | |
| 3/16/2018 | 54FYR99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Northern Border Imports (DNBI) | |
| 12/20/2017 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 5/18/2017 | 54FBL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2120UNSFDIETSP | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Satimed Uab's FDA import refusal history?
Satimed Uab (FEI: 3012327258) has 7 FDA import refusal record(s) in our database, spanning from 5/18/2017 to 5/10/2019.
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 3012327258.
What types of violations has Satimed Uab received?
Satimed Uab has been cited for 4 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.