Warning letter
Intuitive Surgical, Inc.: warning letter of Jul 16, 2013
FDA warning letter 406661 · San Francisco District Office
Key facts
| Reference number | 406661 |
|---|---|
| Company | Intuitive Surgical, Inc. |
| Subject | CGMP for Medical Devices/QSR/Medical Device Reporting/Adulterated/Misbranded |
| Issue date | Jul 16, 2013 |
| Posted date | Jul 16, 2013 |
| Issuing office | San Francisco District Office |
| Product type | Devices |
| CFR sections cited | 820, 806.10(b) |
| Inspection city | Sunnyvale |
| Inspection ZIP | 94086 |
| Inspection start date | Apr 1, 2013 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: