FDA Inspection 567064 — Staar Surgical Company
The FDA completed an inspection of Staar Surgical Company on March 4, 2009 in Monrovia, 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
- March 4, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Monrovia, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3167 | 21 CFR 820.198(a) | Complete files maintained |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 3688 | 21 CFR 820.100(a)(1) | Analysis of data/reports from data sources |