LYMA LIFE LTD
⚠️ High Risk
FEI: 3015646995 • London, London • UNITED KINGDOM
FEI Number
3015646995
Location
London, London
Country
UNITED KINGDOMAddress
223-231 Old Marylebone Road, Edison House, London, London, United Kingdom
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
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.
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).
FALSE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
NO TAG
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product to which is not affixed a certification in the form of a label or tag in conformity with section 534(h).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/23/2022 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | Division of Southeast Imports (DSEI) | |
| 11/21/2022 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | Division of Southeast Imports (DSEI) | |
| 11/21/2022 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | Division of Southeast Imports (DSEI) | |
| 11/21/2022 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | Division of Southeast Imports (DSEI) | |
| 11/18/2022 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | Division of Southeast Imports (DSEI) | |
| 11/18/2022 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | Division of Southeast Imports (DSEI) | |
| 11/16/2022 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | Division of Southeast Imports (DSEI) | |
| 11/16/2022 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | Division of Southeast Imports (DSEI) | |
| 11/16/2022 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | Division of Southeast Imports (DSEI) | |
| 11/16/2022 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | Division of Southeast Imports (DSEI) | |
| 11/16/2022 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | Division of Southeast Imports (DSEI) | |
| 11/16/2022 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | Division of Southeast Imports (DSEI) | |
| 11/16/2022 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | Division of Southeast Imports (DSEI) | |
| 11/16/2022 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | Division of Southeast Imports (DSEI) | |
| 11/16/2022 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | Division of Southeast Imports (DSEI) | |
| 11/16/2022 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | Division of Southeast Imports (DSEI) | |
| 11/16/2022 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | Division of Southeast Imports (DSEI) | |
| 11/16/2022 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | Division of Southeast Imports (DSEI) | |
| 11/16/2022 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | Division of Southeast Imports (DSEI) | |
| 11/16/2022 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | Division of Southeast Imports (DSEI) | |
| 11/16/2022 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | Division of Southeast Imports (DSEI) | |
| 11/16/2022 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | Division of Southeast Imports (DSEI) | |
| 11/16/2022 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | Division of Southeast Imports (DSEI) | |
| 11/15/2022 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 223FALSE | Division of Southeast Imports (DSEI) |
| 11/14/2022 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | Division of Southeast Imports (DSEI) | |
| 11/8/2022 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 223FALSE | Division of Southeast Imports (DSEI) |
| 11/8/2022 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 223FALSE | Division of Southeast Imports (DSEI) |
| 11/7/2022 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 223FALSE | Division of Southeast Imports (DSEI) |
| 11/3/2022 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | Division of Southeast Imports (DSEI) | |
| 11/2/2022 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | Division of Southeast Imports (DSEI) | |
| 11/1/2022 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | Division of Southeast Imports (DSEI) | |
| 11/1/2022 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | Division of Southeast Imports (DSEI) | |
| 10/27/2022 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 223FALSE | Division of Southeast Imports (DSEI) |
| 10/20/2022 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 223FALSE | Division of Southeast Imports (DSEI) |
| 10/13/2022 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 260FALSE | Division of Southeast Imports (DSEI) |
| 10/13/2022 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 260FALSE | Division of Southeast Imports (DSEI) |
| 10/12/2022 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 47NON STD | Division of Southeast Imports (DSEI) |
| 10/7/2022 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 223FALSE | Division of Southeast Imports (DSEI) |
| 10/6/2022 | 79OLPOVER-THE-COUNTER POWERED RED/BLUE LIGHT BASED LASER FOR ACNE | Division of Southeast Imports (DSEI) | |
| 10/3/2022 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 223FALSE | Division of Southeast Imports (DSEI) |
| 10/3/2022 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | Division of Southeast Imports (DSEI) | |
| 1/31/2022 | 79OLPOVER-THE-COUNTER POWERED RED/BLUE LIGHT BASED LASER FOR ACNE | Division of Southeast Imports (DSEI) | |
| 3/5/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | Division of Southeast Imports (DSEI) | |
| 3/5/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | Division of Southeast Imports (DSEI) | |
| 2/22/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 2/16/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/12/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 2/12/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 2/12/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 2/12/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 2/12/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 2/12/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/12/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/12/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/12/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 2/12/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 2/12/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 2/12/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/12/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/12/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/12/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/10/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/10/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/10/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/10/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/8/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 2/8/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 2/8/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 2/8/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 2/4/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 2/4/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/3/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/2/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/2/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/2/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/2/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/2/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/2/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/2/2021 | 79HJELAMP, FLUORESCEIN, AC-POWERED | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/2/2021 | 79HJELAMP, FLUORESCEIN, AC-POWERED | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/1/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/1/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/1/2021 | 79HJELAMP, FLUORESCEIN, AC-POWERED | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/1/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/29/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/29/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/29/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/29/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/29/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/29/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/29/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/29/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/29/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/29/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/29/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/28/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/27/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/26/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/26/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/26/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is LYMA LIFE LTD's FDA import refusal history?
LYMA LIFE LTD (FEI: 3015646995) has 117 FDA import refusal record(s) in our database, spanning from 11/6/2020 to 11/23/2022.
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. LYMA LIFE LTD's FEI number is 3015646995.
What types of violations has LYMA LIFE LTD received?
LYMA LIFE LTD has been cited for 10 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 LYMA LIFE LTD come from?
All FDA import refusal data for LYMA LIFE 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.