Pharmaceutical Company Vertex LTD
⚠️ Moderate Risk
FEI: 3016821686 • Kharkov, UA-63 • UKRAINE
FEI Number
3016821686
Location
Kharkov, UA-63
Country
UKRAINEAddress
33, Astronomicheskaya Str., , Kharkov, UA-63, Ukraine
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).
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.
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.
HEALTH C
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 bears an unauthorized nutrient content/health claim.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/18/2023 | 60LBM99ANALGESIC, N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 4/18/2023 | 60LBM99ANALGESIC, N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 4/18/2023 | 60LBM99ANALGESIC, N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 10/5/2020 | 54YYT99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Pharmaceutical Company Vertex LTD's FDA import refusal history?
Pharmaceutical Company Vertex LTD (FEI: 3016821686) has 4 FDA import refusal record(s) in our database, spanning from 10/5/2020 to 4/18/2023.
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. Pharmaceutical Company Vertex LTD's FEI number is 3016821686.
What types of violations has Pharmaceutical Company Vertex LTD received?
Pharmaceutical Company Vertex LTD 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 Pharmaceutical Company Vertex LTD come from?
All FDA import refusal data for Pharmaceutical Company Vertex LTD 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.