Overview
- 2 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2024-09-18.
At a glance
Inspections
2
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 29 Aug 2024 – 18 Sep 2024 | Medical Devices & Rad Health | Clean | |
| 17 Jan 2023 – 10 Feb 2023 | Medical Devices & Rad Health | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Feb 2023
21 CFR 803.50(a)(1)
Report of Death or Serious Injury
Cited by Maida Henesian, Suzanne M Healy, Anil K Kochhar
10 Feb 2023
21 CFR 820.30(g)
Design validation - software validation not performed
Cited by Maida Henesian, Suzanne M Healy, Anil K Kochhar
10 Feb 2023
21 CFR 820.90(b)(1)
Procedures for product review,disposition lack of/inadequate
Cited by Maida Henesian, Suzanne M Healy, Anil K Kochhar
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Outset Medical, Inc.'s 1 Form 483
Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat