GENECINE LTD
⚠️ Moderate Risk
FEI: 3029910760 • Coulsdon, Surrey • UNITED KINGDOM
FEI Number
3029910760
Location
Coulsdon, Surrey
Country
UNITED KINGDOMAddress
Unit 13, Redlands Centre; Redlands, Coulsdon, Surrey, United Kingdom
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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/8/2024 | 54ABY13VITAMIN C (ASCORBIC ACID) | Division of Northeast Imports (DNEI) | |
| 2/8/2024 | 60CBQ48OXYMETAZOLINE HCL (ADRENERGIC) | Division of Northeast Imports (DNEI) | |
| 2/8/2024 | 60LAY01ACETAMINOPHEN (ANALGESIC) | Division of Northeast Imports (DNEI) | |
| 2/8/2024 | 60LAY01ACETAMINOPHEN (ANALGESIC) | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is GENECINE LTD's FDA import refusal history?
GENECINE LTD (FEI: 3029910760) has 4 FDA import refusal record(s) in our database, spanning from 2/8/2024 to 2/8/2024.
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. GENECINE LTD's FEI number is 3029910760.
What types of violations has GENECINE LTD received?
GENECINE LTD has been cited for 5 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 GENECINE LTD come from?
All FDA import refusal data for GENECINE 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.