FDA Inspection 621697 — Soft Computer Consultants, Inc.
The FDA completed an inspection of Soft Computer Consultants, Inc. on September 29, 2009 in Clearwater, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 12 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 29, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Clearwater, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2339 | 21 CFR 820.22 | Quality Audit/Reaudit - documentation |
| 2601 | 21 CFR 820.30(d) | Essential design outputs |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3167 | 21 CFR 820.198(a) | Complete files maintained |
| 3232 | 21 CFR 820.72(a) | Equipment suitability & capability |
| 3302 | 21 CFR 820.100(a)(3) | Identifying corrective & preventive actions |
| 3687 | 21 CFR 820.100(a)(1) | Analysis of data sources |
| 3688 | 21 CFR 820.100(a)(1) | Analysis of data/reports from data sources |
| 3690 | 21 CFR 820.100(a)(3) | Identification of actions needed |
| 3692 | 21 CFR 820.100(a)(4) | CAPA verification/validation of corrective/preventive action |
| 4168 | 21 CFR 820.100(a)(7) | Management review of CAPA |
| 635 | 21 CFR 803.17(b)(1) | Info evaluated to determine if event was reportable |