FDA Inspection
Southern Implants, (Pty.) Ltd.Southern Implants, (Pty.) Ltd. – FDA Inspection, Oct 7, 2010
Record Details
This FDA Inspection record concerns Southern Implants, (Pty.) Ltd., with an inspection on October 7, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 7, 2010
- Product Type
- Devices
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ID · d8ae7993-f4ae-4744-a30b-d31b899bb63c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 685174
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.30(e)Design review - documentation
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Other FDA inspections of Southern Implants, (Pty.) Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 28, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 19, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Southern Implants, (Pty.) Ltd.
- FDA Inspection 977041 - 2016-01-28
- FDA Inspection 795539 - 2012-07-19
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