Kindeva Drug Delivery Limited
⚠️ Moderate Risk
FEI: 3002807586 • Loughborough, Leicestershire • UNITED KINGDOM
FEI Number
3002807586
Location
Loughborough, Leicestershire
Country
UNITED KINGDOMAddress
Derby Road, , Loughborough, Leicestershire, 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
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/1/2019 | 61EDQ99ANTI-ASTHMATIC, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/24/2016 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 4/26/2007 | 62VCJ99ANTI-VIRAL N.E.C. | Los Angeles District Office (LOS-DO) | |
| 4/26/2007 | 61DCA99ANTI-ANGINAL, N.E.C. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Kindeva Drug Delivery Limited's FDA import refusal history?
Kindeva Drug Delivery Limited (FEI: 3002807586) has 4 FDA import refusal record(s) in our database, spanning from 4/26/2007 to 2/1/2019.
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. Kindeva Drug Delivery Limited's FEI number is 3002807586.
What types of violations has Kindeva Drug Delivery Limited received?
Kindeva Drug Delivery Limited has been cited for 2 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 Kindeva Drug Delivery Limited come from?
All FDA import refusal data for Kindeva Drug Delivery 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.