FDA Inspection 663510 — The Standing Company
The FDA completed an inspection of The Standing Company on May 20, 2010 in Saginaw, MI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 20, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Saginaw, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2270 | 21 CFR 820.20(a) | Implement quality policy |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3224 | 21 CFR 820.70(g)(2) | Periodic equipment inspection lack of or inadequate procedu |
| 3300 | 21 CFR 820.100(a)(1) | Statistical methodology |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 4189 | 21 CFR 820.198(a) | General |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |