Sobytek Instruments Company
⚠️ Moderate Risk
FEI: 3004784004 • Sialkot, Punjab • PAKISTAN
FEI Number
3004784004
Location
Sialkot, Punjab
Country
PAKISTANAddress
28-32-Soby AG Building Daska, , 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
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/26/2023 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/23/2020 | 76JEXPLIER, ORTHODONTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/23/2020 | 79HTDFORCEPS | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/23/2020 | 76ECNCLAMP, WIRE, ORTHODONTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/23/2020 | 76EIRSCISSORS, COLLAR AND CROWN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/23/2020 | 76JEXPLIER, ORTHODONTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/23/2020 | 76JEXPLIER, ORTHODONTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/17/2018 | 76EHYTRAY, IMPRESSION, PREFORMED | Division of Southeast Imports (DSEI) | |
| 1/17/2018 | 76EHYTRAY, IMPRESSION, PREFORMED | Division of Southeast Imports (DSEI) | |
| 1/17/2018 | 76EHYTRAY, IMPRESSION, PREFORMED | Division of Southeast Imports (DSEI) | |
| 1/17/2018 | 76EHYTRAY, IMPRESSION, PREFORMED | Division of Southeast Imports (DSEI) | |
| 1/17/2018 | 76EHYTRAY, IMPRESSION, PREFORMED | Division of Southeast Imports (DSEI) | |
| 1/17/2018 | 76EHYTRAY, IMPRESSION, PREFORMED | Division of Southeast Imports (DSEI) | |
| 1/17/2018 | 76EHYTRAY, IMPRESSION, PREFORMED | Division of Southeast Imports (DSEI) | |
| 1/17/2018 | 76EHYTRAY, IMPRESSION, PREFORMED | Division of Southeast Imports (DSEI) | |
| 1/17/2018 | 76EHYTRAY, IMPRESSION, PREFORMED | Division of Southeast Imports (DSEI) | |
| 4/17/2006 | 78FDYDEVICE, MEASURING, FOR PANENDOSCOPE | 2780DEVICEGMPS | Cincinnati District Office (CIN-DO) |
| 4/17/2006 | 79HTEELEVATOR | 2780DEVICEGMPS | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Sobytek Instruments Company's FDA import refusal history?
Sobytek Instruments Company (FEI: 3004784004) has 18 FDA import refusal record(s) in our database, spanning from 4/17/2006 to 9/26/2023.
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. Sobytek Instruments Company's FEI number is 3004784004.
What types of violations has Sobytek Instruments Company received?
Sobytek Instruments Company 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 Sobytek Instruments Company come from?
All FDA import refusal data for Sobytek Instruments Company 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.