Kundan Kidney Care Centre
⚠️ Moderate Risk
FEI: 3008902822 • Jalandhar City, Punjab • INDIA
FEI Number
3008902822
Location
Jalandhar City, Punjab
Country
INDIAAddress
257/6 Vij Nagar, Hoshiarpur Road, Jalandhar City, Punjab, India
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/9/2012 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 5/11/2012 | 54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/23/2011 | 63XCY99DIAGOSTIC AID (DRUGS) N.E.C. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 6/23/2011 | 63XCY99DIAGOSTIC AID (DRUGS) N.E.C. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 6/23/2011 | 63XCY99DIAGOSTIC AID (DRUGS) N.E.C. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 6/23/2011 | 63XCY99DIAGOSTIC AID (DRUGS) N.E.C. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Kundan Kidney Care Centre's FDA import refusal history?
Kundan Kidney Care Centre (FEI: 3008902822) has 6 FDA import refusal record(s) in our database, spanning from 6/23/2011 to 8/9/2012.
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. Kundan Kidney Care Centre's FEI number is 3008902822.
What types of violations has Kundan Kidney Care Centre received?
Kundan Kidney Care Centre 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 Kundan Kidney Care Centre come from?
All FDA import refusal data for Kundan Kidney Care Centre 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.