FDA Inspection 1081438 — Compumedics USA, Inc
The FDA completed an inspection of Compumedics USA, Inc on March 5, 2019 in Charlotte, NC. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 5, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Charlotte, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3147 | 21 CFR 820.170(a) | Lack of or inadequate instructions |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 3345 | 21 CFR 820.200(a) | Servicing - Lack of or inadequate procedures |
| 3346 | 21 CFR 820.200(b) | Analyzing service report |