FDA Inspection 934448 — Compumedics USA, Inc
The FDA completed an inspection of Compumedics USA, Inc on May 7, 2015 in Charlotte, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 7, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Charlotte, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3266 | 21 CFR 820.86 | Acceptance status |
| 3323 | 21 CFR 820.170(b) | Installer records |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |