FDA Inspection 1082740 — Pacific Medical Group, Inc. DBA Avante Health Solutions
The FDA completed an inspection of Pacific Medical Group, Inc. DBA Avante Health Solutions on March 14, 2019 in San Clemente, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 14, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- San Clemente, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |