Kudos Laboratories
⚠️ High Risk
FEI: 3010617509 • New Delhi, Delhi • INDIA
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
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.
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 |
|---|---|---|---|
| 10/29/2014 | 54FDA99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 10/2/2014 | 54FBY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 8/28/2014 | 54FYY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 8/28/2014 | 54FYY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 8/28/2014 | 54FYY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 8/28/2014 | 54FYY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 8/28/2014 | 54FYY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 8/28/2014 | 54FYY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 8/25/2014 | 54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/21/2014 | 54FYY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/21/2014 | 54FYY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/21/2014 | 54FYY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/21/2014 | 54FYY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/21/2014 | 54FYY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/21/2014 | 54FYY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 5/14/2014 | 66YDR99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Cincinnati District Office (CIN-DO) | |
| 5/14/2014 | 66YDE99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Cincinnati District Office (CIN-DO) | |
| 5/14/2014 | 66YDE99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Cincinnati District Office (CIN-DO) | |
| 5/14/2014 | 61VDA99ANTI-FLATULENT N.E.C. | Cincinnati District Office (CIN-DO) | |
| 5/14/2014 | 66YDE99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Cincinnati District Office (CIN-DO) | |
| 5/14/2014 | 56YDY99ANTIBIOTIC N.E.C. | Cincinnati District Office (CIN-DO) | |
| 4/14/2014 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Kudos Laboratories's FDA import refusal history?
Kudos Laboratories (FEI: 3010617509) has 22 FDA import refusal record(s) in our database, spanning from 4/14/2014 to 10/29/2014.
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. Kudos Laboratories's FEI number is 3010617509.
What types of violations has Kudos Laboratories received?
Kudos Laboratories has been cited for 3 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 Kudos Laboratories come from?
All FDA import refusal data for Kudos Laboratories 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.