FDA Inspection 572316 — Haemonetics Software Solutions
The FDA completed an inspection of Haemonetics Software Solutions on Mar 13, 2009 in Rosemont, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 13, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Rosemont, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2598 | 21 CFR 820.30(d) | Design output procedures |
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |
| 3299 | 21 CFR 820.100(a)(1) | Procedure for analysis of data sources |
| 3301 | 21 CFR 820.100(a)(2) | Investigation procedures |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |