Southern Implants, (Pty.) Ltd.
⚠️ Moderate Risk
FEI: 3003394627 • Gauteng • SOUTH AFRICA
FEI Number
3003394627
Location
Gauteng
Country
SOUTH AFRICAAddress
One Albert Road, , Irene, Gauteng, , South Africa
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
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.
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).
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 |
|---|---|---|---|
| 6/4/2012 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 2780DEVICEGMPS | New Orleans District Office (NOL-DO) |
| 6/4/2012 | 76DZADRILL, DENTAL, INTRAORAL | 2780DEVICEGMPS | New Orleans District Office (NOL-DO) |
| 6/4/2012 | 76EIFACCESSORIES, RETRACTOR, DENTAL | 2780DEVICEGMPS | New Orleans District Office (NOL-DO) |
| 6/4/2012 | 76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | 2780DEVICEGMPS | New Orleans District Office (NOL-DO) |
| 6/4/2012 | 76DZEIMPLANT, ENDOSSEOUS | 2780DEVICEGMPS | New Orleans District Office (NOL-DO) |
| 10/28/2011 | 76EIFACCESSORIES, RETRACTOR, DENTAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 10/28/2011 | 76ELZCROWN, PREFORMED | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 10/28/2011 | 76DZADRILL, DENTAL, INTRAORAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/19/2011 | 76DZADRILL, DENTAL, INTRAORAL | 2780DEVICEGMPS | New Orleans District Office (NOL-DO) |
| 8/19/2011 | 76EIFACCESSORIES, RETRACTOR, DENTAL | 2780DEVICEGMPS | New Orleans District Office (NOL-DO) |
| 8/19/2011 | 76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | 2780DEVICEGMPS | New Orleans District Office (NOL-DO) |
| 8/5/2011 | 76EILGAUGE, DEPTH, INSTRUMENT, DENTAL | 2780DEVICEGMPS | New Orleans District Office (NOL-DO) |
| 8/5/2011 | 76OFXGENERAL PURPOSE DENTAL TRAY | 2780DEVICEGMPS | New Orleans District Office (NOL-DO) |
| 8/5/2011 | 76DZLSCREW, FIXATION, INTRAOSSEOUS | 2780DEVICEGMPS | New Orleans District Office (NOL-DO) |
| 8/5/2011 | 76ECTDRIVER, BAND, ORTHODONTIC | 2780DEVICEGMPS | New Orleans District Office (NOL-DO) |
| 8/5/2011 | 76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | 2780DEVICEGMPS | New Orleans District Office (NOL-DO) |
| 8/5/2011 | 76DZADRILL, DENTAL, INTRAORAL | 2780DEVICEGMPS | New Orleans District Office (NOL-DO) |
| 8/5/2011 | 76OATIMPLANT, ENDOSSEOUS, ORTHODONTIC | 2780DEVICEGMPS | New Orleans District Office (NOL-DO) |
| 8/12/2002 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | 508NO 510(K) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Southern Implants, (Pty.) Ltd.'s FDA import refusal history?
Southern Implants, (Pty.) Ltd. (FEI: 3003394627) has 19 FDA import refusal record(s) in our database, spanning from 8/12/2002 to 6/4/2012.
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. Southern Implants, (Pty.) Ltd.'s FEI number is 3003394627.
What types of violations has Southern Implants, (Pty.) Ltd. received?
Southern Implants, (Pty.) Ltd. 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 Southern Implants, (Pty.) Ltd. come from?
All FDA import refusal data for Southern Implants, (Pty.) 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.