FDA Inspection
Outset Medical, Inc.Outset Medical, Inc. – FDA Inspection, Jul 22, 2026
Record Details
This FDA Inspection record concerns Outset Medical, Inc., with an inspection on July 22, 2026, issued by the San Francisco District Office, covering medical devices & rad health.
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ID · f76609ec-7cd5-4e00-ba8e-3d6feb00afdf
Inspection Facts
- Inspection number
- 1317782
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.56Submission of Supplement to Individual Report Within One Month
- ISO 13485:2016 Clause 4.1.5Inadequate monitoring and control over outsourced processes
- ISO 13485:2016 Clause 7.3.9Procedures to control design and development changes not documented
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures not documented
- ISO 13485:2016 Clause 8.4Analysis of data not used as input for QMS improvement where necessary
- ISO 13485:2016 Clause 8.5.2Corrective action not taken
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Other FDA inspections of Outset Medical, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 18, 2024 | Not classified | San Francisco District Office | |
| February 10, 2023 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Outset Medical, Inc.
- FDA Inspection 1251442 - 2024-09-18
- FDA Inspection 1196985 - 2023-02-10
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