FDA Inspection 834307 — Haemoscope Division Of Haemonetics Corp
The FDA completed an inspection of Haemoscope Division Of Haemonetics Corp on May 24, 2013 in Niles, 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 24, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Niles, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3155 | 21 CFR 820.181(a) | DMR device specifications |
| 3671 | 21 CFR 820.25(a) | Personnel |