Vemo 99 Ltd., Limited
⚠️ Moderate Risk
FEI: 3006942906 • Sofia, Sofia-Grad • BULGARIA
FEI Number
3006942906
Location
Sofia, Sofia-Grad
Country
BULGARIAAddress
Rozhen Blvd. 88, , Sofia, Sofia-Grad, Bulgaria
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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 |
|---|---|---|---|
| 3/16/2016 | 54FBE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/2/2015 | 54FBR89TRIBULUS (HERBAL & BOTANICALS, NOT TEAS) | Los Angeles District Office (LOS-DO) | |
| 10/16/2013 | 54YIZ99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | New York District Office (NYK-DO) | |
| 5/29/2013 | 66VCE99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Vemo 99 Ltd., Limited's FDA import refusal history?
Vemo 99 Ltd., Limited (FEI: 3006942906) has 4 FDA import refusal record(s) in our database, spanning from 5/29/2013 to 3/16/2016.
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. Vemo 99 Ltd., Limited's FEI number is 3006942906.
What types of violations has Vemo 99 Ltd., Limited received?
Vemo 99 Ltd., Limited has been cited for 3 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 Vemo 99 Ltd., Limited come from?
All FDA import refusal data for Vemo 99 Ltd., Limited 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.