FDA Warning Letter — Outset Medical, Inc.
The FDA took a Warning Letter action against Outset Medical, Inc. on July 5, 2023 (San Jose, CA). The action was issued by CDRH and concerns devices products. This facility has 2 recent FDA inspections on record.
Action Details
- Facility
- Outset Medical, Inc.
- Date
- July 5, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Center
- CDRH
- Location
- San Jose, CA (United States)