Hani Instruments
⚠️ Moderate Risk
FEI: 3009435510 • 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/23/2012 | 76ECNCLAMP, WIRE, ORTHODONTIC | Cincinnati District Office (CIN-DO) | |
| 3/23/2012 | 76EGNSCISSORS, SURGICAL TISSUE, DENTAL | Cincinnati District Office (CIN-DO) | |
| 3/23/2012 | 77KBNGAG, MOUTH | Cincinnati District Office (CIN-DO) | |
| 3/23/2012 | 76EMJELEVATOR, SURGICAL, DENTAL | Cincinnati District Office (CIN-DO) | |
| 3/23/2012 | 76EMGFORCEPS, TOOTH EXTRACTOR, SURGICAL | Cincinnati District Office (CIN-DO) | |
| 3/23/2012 | 76EICSYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Hani Instruments's FDA import refusal history?
Hani Instruments (FEI: 3009435510) has 6 FDA import refusal record(s) in our database, spanning from 3/23/2012 to 3/23/2012.
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. Hani Instruments's FEI number is 3009435510.
What types of violations has Hani Instruments received?
Hani Instruments has been cited for 2 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 Hani Instruments come from?
All FDA import refusal data for Hani Instruments 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.