Company
South AfricaSouthern Implants, (Pty.) Ltd., Irene, Gauteng, South Africa – FDA Inspections
Inspection records and compliance data for Southern Implants, (Pty.) Ltd. in Irene, Gauteng. 3 FDA inspections on record (1 OAI), last inspected January 28, 2016.
Company Profile
This profile covers Southern Implants, (Pty.) Ltd. based in Irene, Gauteng, South Africa.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 0
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected October 7, 2010. Last inspected January 28, 2016.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design history file1 inspection
- Design input - documentation1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 28, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 977041 |
| July 19, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 795539 |
| October 7, 2010 | OAI | Medical Devices & Rad Health · Compliance: Devices | 685174 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Southern Implants, (Pty.) Ltd.
FEI Number
3003394627
Address
One Albert Road, Irene, Gauteng, South Africa
Country
South Africa
ID: 63bc3b00-b8ed-4e83-a401-2564f160cd01