Khushbu Impex
⚠️ Moderate Risk
FEI: 3008313445 • Mumbai, Maharashtra • INDIA
FEI Number
3008313445
Location
Mumbai, Maharashtra
Country
INDIAAddress
Play Ground Road, , Mumbai, Maharashtra, 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
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/26/2016 | 56JCK20CLINDAMYCIN HYDROCHLORIDE HYDRATE (LINCOMYCINS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/5/2015 | 62GAA46KETOPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 8/5/2015 | 64LCA41HYDROCORTISONE SODIUM SUCCINATE (GLUCOCORTICOID) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/8/2015 | 64LCA41HYDROCORTISONE SODIUM SUCCINATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/6/2015 | 60LCL99ANALGESIC, N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/6/2014 | 64UBB04CILASTATIN SODIUM/IMIPENEM (INHIBITOR (DECARBOXYLASE)) | Division of Southeast Imports (DSEI) | |
| 3/19/2014 | 56JAA22CLINDAMYCIN PHOSPHATE (LINCOMYCINS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/24/2011 | 61FAE53CEFADROXIL MONOHYDRATE (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | Division of Southeast Imports (DSEI) | |
| 10/26/2010 | 61GCL80MEROPENEM (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/5/2010 | 62VCA18ACYCLOVIR (ANTI-VIRAL) | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Khushbu Impex's FDA import refusal history?
Khushbu Impex (FEI: 3008313445) has 10 FDA import refusal record(s) in our database, spanning from 5/5/2010 to 4/26/2016.
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. Khushbu Impex's FEI number is 3008313445.
What types of violations has Khushbu Impex received?
Khushbu Impex 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 Khushbu Impex come from?
All FDA import refusal data for Khushbu 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.