Sobytex Inst
⚠️ Moderate Risk
FEI: 3005657093 • Sialkot, Punjab • PAKISTAN
FEI Number
3005657093
Location
Sialkot, Punjab
Country
PAKISTANAddress
Circua Rpoad, , 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/1/2013 | 76EIRSCISSORS, COLLAR AND CROWN | 290DE IMP GMP | New York District Office (NYK-DO) |
| 7/1/2013 | 76JEXPLIER, ORTHODONTIC | 290DE IMP GMP | New York District Office (NYK-DO) |
| 7/1/2013 | 76EIKCARVER, WAX, DENTAL | 290DE IMP GMP | New York District Office (NYK-DO) |
| 7/1/2013 | 79HTDFORCEPS | 290DE IMP GMP | New York District Office (NYK-DO) |
| 7/1/2013 | 76JEXPLIER, ORTHODONTIC | 290DE IMP GMP | New York District Office (NYK-DO) |
| 7/1/2013 | 79FTYTAPE, MEASURING, RULERS AND CALIPERS | 290DE IMP GMP | New York District Office (NYK-DO) |
| 6/26/2007 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 6/26/2007 | 79JEBTABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, MANUAL | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 6/26/2007 | 79JEBTABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, MANUAL | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 6/26/2007 | 79JEBTABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, MANUAL | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 6/26/2007 | 79JEBTABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, MANUAL | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 6/26/2007 | 79JEBTABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, MANUAL | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 6/26/2007 | 79JEBTABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, MANUAL | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 6/26/2007 | 79JEBTABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, MANUAL | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 6/26/2007 | 79JEBTABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, MANUAL | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 6/26/2007 | 76EIFACCESSORIES, RETRACTOR, DENTAL | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 6/26/2007 | 79GADRETRACTOR, SURGICAL, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Sobytex Inst's FDA import refusal history?
Sobytex Inst (FEI: 3005657093) has 17 FDA import refusal record(s) in our database, spanning from 6/26/2007 to 7/1/2013.
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. Sobytex Inst's FEI number is 3005657093.
What types of violations has Sobytex Inst received?
Sobytex Inst has been cited for 1 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 Sobytex Inst come from?
All FDA import refusal data for Sobytex Inst 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.