HIJ NTN 5245097
⚠️ Moderate Risk
FEI: 3029695729 • Sialkot • PAKISTAN
FEI Number
3029695729
Location
Sialkot
Country
PAKISTANAddress
Umer Center Shahab, , Sialkot, , 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).
DE IMP GMP
The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).
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.
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/28/2023 | 76DZNMATRIX, DENTAL | Division of Southeast Imports (DSEI) | |
| 12/28/2023 | 76EAXMIRROR, MOUTH | Division of Southeast Imports (DSEI) | |
| 12/28/2023 | 76EMJELEVATOR, SURGICAL, DENTAL | Division of Southeast Imports (DSEI) | |
| 12/28/2023 | 76EMNSCALER, PERIODONTIC | Division of Southeast Imports (DSEI) | |
| 12/28/2023 | 76EMGFORCEPS, TOOTH EXTRACTOR, SURGICAL | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is HIJ NTN 5245097's FDA import refusal history?
HIJ NTN 5245097 (FEI: 3029695729) has 5 FDA import refusal record(s) in our database, spanning from 12/28/2023 to 12/28/2023.
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. HIJ NTN 5245097's FEI number is 3029695729.
What types of violations has HIJ NTN 5245097 received?
HIJ NTN 5245097 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 HIJ NTN 5245097 come from?
All FDA import refusal data for HIJ NTN 5245097 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.