AL-KHAIR CREATIVE QUALITY WARE
⚠️ Moderate Risk
FEI: 3004063371 • Karachi, Sindh • PAKISTAN
FEI Number
3004063371
Location
Karachi, Sindh
Country
PAKISTANAddress
Jm932,1/1 Machiyara Mansion, , Karachi, Sindh, Pakistan
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
DV NAME
The article appears to be a device and its labeling fails to bear the proprietary or established name.
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 |
|---|---|---|---|
| 9/10/2014 | 62FBY99ANTI-INFECTIVE, TOPICAL N.E.C. | Minneapolis District Office (MIN-DO) | |
| 1/22/2008 | 76EFWTOOTHBRUSH, MANUAL | Detroit District Office (DET-DO) | |
| 1/22/2008 | 76EFWTOOTHBRUSH, MANUAL | Detroit District Office (DET-DO) | |
| 3/13/2007 | 76EFWTOOTHBRUSH, MANUAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is AL-KHAIR CREATIVE QUALITY WARE's FDA import refusal history?
AL-KHAIR CREATIVE QUALITY WARE (FEI: 3004063371) has 4 FDA import refusal record(s) in our database, spanning from 3/13/2007 to 9/10/2014.
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. AL-KHAIR CREATIVE QUALITY WARE's FEI number is 3004063371.
What types of violations has AL-KHAIR CREATIVE QUALITY WARE received?
AL-KHAIR CREATIVE QUALITY WARE has been cited for 5 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 AL-KHAIR CREATIVE QUALITY WARE come from?
All FDA import refusal data for AL-KHAIR CREATIVE QUALITY WARE 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.