M.A. Arain & Brothers (Pvt) Ltd
⚠️ Moderate Risk
FEI: 3002774183 • Sialkot, Punjab • PAKISTAN
FEI Number
3002774183
Location
Sialkot, Punjab
Country
PAKISTANAddress
Wazirabad Road, , Sialkot, Punjab, 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
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).
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
STAINSTEEL
The article appears to be a device whose quality falls below that which it purports or is represented to possess, in that instrument is represented as stainless steel but does not meet requirements for such steel for surgical instruments.
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 |
|---|---|---|---|
| 4/3/2017 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | 473LABELING | Division of Southeast Imports (DSEI) |
| 10/20/2006 | 76EEJGUARD, DISK | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 10/20/2006 | 76KMYPOSITIONER, TOOTH, PREFORMED | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 10/20/2006 | 76JEXPLIER, ORTHODONTIC | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 10/20/2006 | 76EILGAUGE, DEPTH, INSTRUMENT, DENTAL | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 10/20/2006 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 10/20/2006 | 80FMHCONTAINER, SPECIMEN | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 10/20/2006 | 76EMDHEMOSTAT, SURGICAL | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 6/25/2003 | 76EMGFORCEPS, TOOTH EXTRACTOR, SURGICAL | Florida District Office (FLA-DO) | |
| 8/2/2002 | 76EMGFORCEPS, TOOTH EXTRACTOR, SURGICAL | Florida District Office (FLA-DO) | |
| 12/19/2001 | 76DZADRILL, DENTAL, INTRAORAL | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is M.A. Arain & Brothers (Pvt) Ltd's FDA import refusal history?
M.A. Arain & Brothers (Pvt) Ltd (FEI: 3002774183) has 11 FDA import refusal record(s) in our database, spanning from 12/19/2001 to 4/3/2017.
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. M.A. Arain & Brothers (Pvt) Ltd's FEI number is 3002774183.
What types of violations has M.A. Arain & Brothers (Pvt) Ltd received?
M.A. Arain & Brothers (Pvt) Ltd 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 M.A. Arain & Brothers (Pvt) Ltd come from?
All FDA import refusal data for M.A. Arain & Brothers (Pvt) Ltd 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.