Lativio Llp
⚠️ Moderate Risk
FEI: 3006205650 • Nottinghamnottingham • UNITED KINGDOM
FEI Number
3006205650
Location
Nottinghamnottingham
Country
UNITED KINGDOMAddress
Suite 3a, Park Lane Business Centre, , Nottinghamnottingham, , 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
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.
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.
DANGEROUS
The article appears to be dangerous to health when used in the dosage or manner, or with the frequency or duration, prescribed, recommended, or suggested in the labeling thereof.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/5/2010 | 89ISDEXERCISER, MEASURING | Cincinnati District Office (CIN-DO) | |
| 1/11/2010 | 78JCWPROSTHESIS, PENIS, INFLATABLE | Cincinnati District Office (CIN-DO) | |
| 1/7/2010 | 78JCWPROSTHESIS, PENIS, INFLATABLE | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 1/6/2010 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 1/4/2010 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 12/28/2009 | 78JCWPROSTHESIS, PENIS, INFLATABLE | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 12/28/2009 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 12/28/2009 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 12/23/2009 | 89IODCOMPONENTS, EXERCISE | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 12/23/2009 | 89IODCOMPONENTS, EXERCISE | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 12/10/2009 | 78JCWPROSTHESIS, PENIS, INFLATABLE | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 12/7/2009 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Lativio Llp's FDA import refusal history?
Lativio Llp (FEI: 3006205650) has 12 FDA import refusal record(s) in our database, spanning from 12/7/2009 to 2/5/2010.
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. Lativio Llp's FEI number is 3006205650.
What types of violations has Lativio Llp received?
Lativio Llp 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 Lativio Llp come from?
All FDA import refusal data for Lativio Llp 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.