FDA Inspection 1042434 — American Medical Systems Innovations
The FDA completed an inspection of American Medical Systems Innovations on February 27, 2018 in San Jose, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 27, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- San Jose, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |
| 812 | 21 CFR 803.56 | Submission of Supplement to Individual Report Within One Month |