CURRENTBODY LTD.
⚠️ Moderate Risk
FEI: 3014737458 • Cheadle, Cheshire • UNITED KINGDOM
FEI Number
3014737458
Location
Cheadle, Cheshire
Country
UNITED KINGDOMAddress
Unit D6, Oak Green; Stanley Green Business Park; Commercial Avenue, Cheadle, Cheshire, 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).
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.
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/5/2019 | 79OHTLIGHT BASED OVER-THE-COUNTER HAIR REMOVAL | Division of Northern Border Imports (DNBI) | |
| 11/5/2019 | 79OHTLIGHT BASED OVER-THE-COUNTER HAIR REMOVAL | Division of Northern Border Imports (DNBI) | |
| 11/4/2019 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Division of Northern Border Imports (DNBI) | |
| 11/4/2019 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Division of Northern Border Imports (DNBI) | |
| 10/29/2019 | 79OHTLIGHT BASED OVER-THE-COUNTER HAIR REMOVAL | Division of Northern Border Imports (DNBI) | |
| 10/29/2019 | 79OHTLIGHT BASED OVER-THE-COUNTER HAIR REMOVAL | Division of Northern Border Imports (DNBI) | |
| 10/29/2019 | 79OHTLIGHT BASED OVER-THE-COUNTER HAIR REMOVAL | Division of Northern Border Imports (DNBI) | |
| 10/29/2019 | 79OHTLIGHT BASED OVER-THE-COUNTER HAIR REMOVAL | Division of Northern Border Imports (DNBI) | |
| 10/28/2019 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Division of Northern Border Imports (DNBI) | |
| 10/28/2019 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Division of Northern Border Imports (DNBI) | |
| 10/28/2019 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Division of Northern Border Imports (DNBI) | |
| 10/28/2019 | 79ONGPOWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM\FRACTIONAL OUTPUT | Division of Northern Border Imports (DNBI) | |
| 10/28/2019 | 79OLPOVER-THE-COUNTER POWERED RED/BLUE LIGHT BASED LASER FOR ACNE | Division of Northern Border Imports (DNBI) | |
| 10/28/2019 | 79OLPOVER-THE-COUNTER POWERED RED/BLUE LIGHT BASED LASER FOR ACNE | Division of Northern Border Imports (DNBI) | |
| 10/28/2019 | 79OAPLASER, COMB, HAIR | Division of Northern Border Imports (DNBI) | |
| 10/28/2019 | 79ONGPOWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM\FRACTIONAL OUTPUT | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 6/3/2019 | 79OHTLIGHT BASED OVER-THE-COUNTER HAIR REMOVAL | Division of Southeast Imports (DSEI) | |
| 11/13/2018 | 79OHTLIGHT BASED OVER-THE-COUNTER HAIR REMOVAL | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is CURRENTBODY LTD.'s FDA import refusal history?
CURRENTBODY LTD. (FEI: 3014737458) has 18 FDA import refusal record(s) in our database, spanning from 11/13/2018 to 11/5/2019.
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. CURRENTBODY LTD.'s FEI number is 3014737458.
What types of violations has CURRENTBODY LTD. received?
CURRENTBODY 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 CURRENTBODY LTD. come from?
All FDA import refusal data for CURRENTBODY 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.