Aaaz Instruments
⚠️ Moderate Risk
FEI: 3007055806 • Sialkot • PAKISTAN
FEI Number
3007055806
Location
Sialkot
Country
PAKISTANAddress
Mughal Pura Post Office Pur Town, , 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).
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/3/2008 | 79GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE | New York District Office (NYK-DO) | |
| 10/3/2008 | 76EFKFORCEPS, ARTICULATION PAPER | New York District Office (NYK-DO) | |
| 10/3/2008 | 76EKICARRIER, AMALGAM, OPERATIVE | New York District Office (NYK-DO) | |
| 9/23/2008 | 79FZSCURETTE, SURGICAL | New York District Office (NYK-DO) | |
| 9/23/2008 | 76EJEFRAME, RUBBER DAM | New York District Office (NYK-DO) | |
| 9/23/2008 | 76EMIFILE, BONE, SURGICAL | New York District Office (NYK-DO) | |
| 9/23/2008 | 76EMJELEVATOR, SURGICAL, DENTAL | New York District Office (NYK-DO) | |
| 9/23/2008 | 76DZNMATRIX, DENTAL | New York District Office (NYK-DO) | |
| 9/23/2008 | 76EMGFORCEPS, TOOTH EXTRACTOR, SURGICAL | New York District Office (NYK-DO) | |
| 9/23/2008 | 76EKJBURNISHER, OPERATIVE | New York District Office (NYK-DO) | |
| 9/23/2008 | 79FZSCURETTE, SURGICAL | New York District Office (NYK-DO) | |
| 9/23/2008 | 76EAXMIRROR, MOUTH | New York District Office (NYK-DO) | |
| 9/23/2008 | 76EMNSCALER, PERIODONTIC | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Aaaz Instruments's FDA import refusal history?
Aaaz Instruments (FEI: 3007055806) has 13 FDA import refusal record(s) in our database, spanning from 9/23/2008 to 10/3/2008.
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. Aaaz Instruments's FEI number is 3007055806.
What types of violations has Aaaz Instruments received?
Aaaz Instruments 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 Aaaz Instruments come from?
All FDA import refusal data for Aaaz 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.