FDA Inspection 680387 — Haemoscope Division Of Haemonetics Corp
The FDA completed an inspection of Haemoscope Division Of Haemonetics Corp on Sep 9, 2010 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 9, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Niles, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |