Outset Medical, Inc.
Form 483 issued February 10, 2023 · San Jose, California
- Inspection
- Jan 17 – Feb 10, 2023
- Investigators
- Anil K. Kochhar· Maida Henesian· Suzanne M. Healy
- Observations
- 4
- Pages
- 5
- FEI number
- 3010355846
In short: On February 10, 2023, FDA issued a Form 483 with 4 observations to Outset Medical, Inc. in San Jose, California (FEI 3010355846) after an inspection that ran Jan 17 – Feb 10, 2023. The investigators were Anil K. Kochhar, Maida Henesian and Suzanne M. Healy. Most observations concern cAPA and design controls.
At a glance
3 of 4 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
- 02
Validation of device software…
- 03
Procedures that define the responsibility for review and the authority for the disposition of nonconforming product…
- 04
Corrective and preventive action activities and/or results…
This inspection in context
Anil K. Kochhar
1 document · 2023
Cites 803.50(a)(1) (if i am a manufacturer, what reporting requirements apply to me?) more than any other section. Most of their documents are for sites in California.
The firmOutset Medical, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 803.50(a)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Outset Medical, Inc.?
FDA listed 4 observations on this Form 483, mostly about cAPA and design controls. The opening words of each observation are shown on this page.
Who inspected Outset Medical, Inc.?
Anil K. Kochhar, Maida Henesian and Suzanne M. Healy are named on this Form 483, for the inspection of Jan 17 – Feb 10, 2023. Each investigator has a profile showing what they cite most.
When was Outset Medical, Inc. inspected by FDA?
The inspection ran Jan 17 – Feb 10, 2023, and the Form 483 is dated February 10, 2023.
How do I get the full Form 483 for Outset Medical, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.