OPATRA LIMITED
⚠️ High Risk
FEI: 3012541016 • London, Hry • UNITED KINGDOM
FEI Number
3012541016
Location
London, Hry
Country
UNITED KINGDOMAddress
Gatwick Road, 447 High Road, London, Hry, 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.
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).
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).
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.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
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.
DV NAME
The article appears to be a device and its labeling fails to bear the proprietary or established name.
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.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/20/2024 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 11/20/2024 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 11/20/2024 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 11/20/2024 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 11/20/2024 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 8/17/2022 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 8/17/2022 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 8/26/2021 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/28/2021 | 79OLIFAT REDUCING LOW LEVEL LASER | Division of Southeast Imports (DSEI) | |
| 3/5/2021 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 237NO PMA | Division of Southeast Imports (DSEI) |
| 10/2/2020 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 8/17/2020 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 7/24/2020 | 89IRPMASSAGER, POWERED INFLATABLE TUBE | Division of Northern Border Imports (DNBI) | |
| 6/3/2020 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 6/3/2020 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Division of West Coast Imports (DWCI) | |
| 5/12/2020 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/15/2018 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 336INCONSPICU | Division of Southeast Imports (DSEI) |
| 4/20/2018 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is OPATRA LIMITED's FDA import refusal history?
OPATRA LIMITED (FEI: 3012541016) has 18 FDA import refusal record(s) in our database, spanning from 4/20/2018 to 11/20/2024.
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. OPATRA LIMITED's FEI number is 3012541016.
What types of violations has OPATRA LIMITED received?
OPATRA LIMITED 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 OPATRA LIMITED come from?
All FDA import refusal data for OPATRA 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.