FDA Inspection 731535 — Soft Computer Consultants, Inc.
The FDA completed an inspection of Soft Computer Consultants, Inc. on May 25, 2011 in Clearwater, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 18 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 25, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Clearwater, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 14718 | 21 CFR 820.30(g) | Design validation - Risk analysis |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3175 | 21 CFR 820.186 | QSR |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 3674 | 21 CFR 820.30(d) | Design output - documentation |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |
| 635 | 21 CFR 803.17(b)(1) | Info evaluated to determine if event was reportable |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |