FDA Inspection 832849 — Intuitive Surgical, Inc.
The FDA completed an inspection of Intuitive Surgical, Inc. on May 30, 2013 in Sunnyvale, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 30, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Sunnyvale, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |
| 4201 | 21 CFR 806.10(c)(8) | Illness report |