Ilmi Kitab Ghar
⚠️ Moderate Risk
FEI: 3009528312 • Karachi, Sindh • PAKISTAN
FEI Number
3009528312
Location
Karachi, Sindh
Country
PAKISTANAddress
Asan Mal Oja Road Urdu Bazar, , 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
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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).
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
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).
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 |
|---|---|---|---|
| 2/15/2017 | 61HDY99ANTI-BACTERIAL, N.E.C. | Division of Northeast Imports (DNEI) | |
| 2/15/2017 | 53GH99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C. | 197COSM COLOR | Division of Northeast Imports (DNEI) |
| 2/15/2017 | 61HDY99ANTI-BACTERIAL, N.E.C. | Division of Northeast Imports (DNEI) | |
| 10/5/2016 | 76EFWTOOTHBRUSH, MANUAL | 341REGISTERED | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Ilmi Kitab Ghar's FDA import refusal history?
Ilmi Kitab Ghar (FEI: 3009528312) has 4 FDA import refusal record(s) in our database, spanning from 10/5/2016 to 2/15/2017.
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. Ilmi Kitab Ghar's FEI number is 3009528312.
What types of violations has Ilmi Kitab Ghar received?
Ilmi Kitab Ghar 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 Ilmi Kitab Ghar come from?
All FDA import refusal data for Ilmi Kitab Ghar 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.