Cyrex Ltd
⚠️ Moderate Risk
FEI: 3011688026 • Pindar Road • UNITED KINGDOM
FEI Number
3011688026
Location
Pindar Road
Country
UNITED KINGDOMAddress
Unit 36 Hoddesdon Industrial Cen, , Pindar Road, , 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.
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.
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 |
|---|---|---|---|
| 8/16/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/3/2016 | 85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE | New Orleans District Office (NOL-DO) | |
| 8/3/2016 | 85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE | New Orleans District Office (NOL-DO) | |
| 8/3/2016 | 73BXMSTIMULATOR, NERVE, AC-POWERED | New Orleans District Office (NOL-DO) | |
| 8/3/2016 | 85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE | New Orleans District Office (NOL-DO) | |
| 4/15/2016 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 3/17/2016 | 89IROVIBRATOR, THERAPEUTIC | New Orleans District Office (NOL-DO) | |
| 3/16/2016 | 78KOEDILATOR, URETHRAL | New Orleans District Office (NOL-DO) | |
| 3/8/2016 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Los Angeles District Office (LOS-DO) | |
| 3/7/2016 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Los Angeles District Office (LOS-DO) | |
| 2/8/2016 | 79JOTELECTRODE, GEL, ELECTROSURGICAL | New Orleans District Office (NOL-DO) | |
| 2/8/2016 | 80KMJLUBRICANT, PATIENT | New Orleans District Office (NOL-DO) | |
| 2/8/2016 | 84GZJSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF | New Orleans District Office (NOL-DO) | |
| 1/25/2016 | 80KMJLUBRICANT, PATIENT | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Cyrex Ltd's FDA import refusal history?
Cyrex Ltd (FEI: 3011688026) has 14 FDA import refusal record(s) in our database, spanning from 1/25/2016 to 8/16/2016.
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. Cyrex Ltd's FEI number is 3011688026.
What types of violations has Cyrex Ltd received?
Cyrex 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 Cyrex Ltd come from?
All FDA import refusal data for Cyrex 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.