KING IMPEX
⚠️ Moderate Risk
FEI: 3013607619 • New Delhi, Delhi • INDIA
FEI Number
3013607619
Location
New Delhi, Delhi
Country
INDIAAddress
623 O Road, , New Delhi, Delhi, 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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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.
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 |
|---|---|---|---|
| 10/18/2017 | 63RBY99DENTAL CARIES PROPHYLACTIC N.E.C. | Division of West Coast Imports (DWCI) | |
| 10/18/2017 | 62GBJ99ANTI-INFLAMMATORY N.E.C. | Division of West Coast Imports (DWCI) | |
| 10/18/2017 | 65GBJ99PIGMENTATION AGENT N.E.C. | Division of West Coast Imports (DWCI) | |
| 10/18/2017 | 65GBJ99PIGMENTATION AGENT N.E.C. | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is KING IMPEX's FDA import refusal history?
KING IMPEX (FEI: 3013607619) has 4 FDA import refusal record(s) in our database, spanning from 10/18/2017 to 10/18/2017.
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. KING IMPEX's FEI number is 3013607619.
What types of violations has KING IMPEX received?
KING IMPEX 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 KING IMPEX come from?
All FDA import refusal data for KING IMPEX 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.