FDA Inspection 685174 — Southern Implants, (Pty.) Ltd.
The FDA completed an inspection of Southern Implants, (Pty.) Ltd. on October 7, 2010 in Irene, Gauteng. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 7, 2010
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Irene, Gauteng (South Africa)
Citations
| ID | CFR | Description |
|---|---|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 2630 | 21 CFR 820.30(e) | Design review - documentation |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 4212 | 21 CFR 806.20(b)(4) | Justification for not reporting |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |