FDA Inspection 881917 — Pacific Medical Group, Inc. DBA Avante Health Solutions
The FDA completed an inspection of Pacific Medical Group, Inc. DBA Avante Health Solutions on June 6, 2014 in San Clemente, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- June 6, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- San Clemente, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |