Outset Medical, Inc.
FDA inspection history in San Jose, California, 2023
- 1
- Warning letter
- 1
- Form 483
- 1
- Close-out
Every document, by year
- Warning letter
- Form 483
- Close-out
2023: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2023One warning letter and one Form 483, at San Jose, California.
Cited most
Across all Outset Medical observations on file
- 21 CFR 803.50(a)(1)If I am a manufacturer, what reporting requirements apply to me?1
- 21 CFR 820.100(b)Corrective and preventive action1
- 21 CFR 820.30(g)Design controls1
- 21 CFR 820.90(b)(1)Nonconforming product1
The complete Outset Medical file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
San Jose, California
One warning letter, one Form 483 and one close-out letter · 2023 · 4 observations
Latest: Warning letter, Jul 5, 2023 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-07-05 | Warning letter Warning letter | San Jose, California | — | $99 |
| 2023-02-10 | 483 Form 483 | San Jose, California | 4 | $99 |
| Undated | Close-out Close-out letter | San Jose, California | — | $99 |
Investigators on these documents
FEI number 3010355846 · most recent document Jul 5, 2023
About Outset Medical, Inc.
How many FDA Form 483s has Outset Medical, Inc. received?
FDA Intel has 1 Form 483 on file for Outset Medical, Inc.; the most recent is dated Feb 10, 2023.
When was Outset Medical, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Outset Medical, Inc. is a Form 483 dated Feb 10, 2023, for the site in San Jose, California.
What did FDA cite at Outset Medical, Inc.?
The regulations cited most in the observations on file for Outset Medical, Inc. are 21 CFR 803.50(a)(1) (If I am a manufacturer, what reporting requirements apply to me?), 1 time; 21 CFR 820.100(b) (Corrective and preventive action), 1 time; 21 CFR 820.30(g) (Design controls), 1 time.
Has Outset Medical, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Outset Medical, Inc.; the most recent is dated Jul 5, 2023.