Koios Medical, Inc
FDA inspection history in New York, New York, 2021
- 1
- Form 483
Every document, by year
- Form 483
2021: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021One Form 483, at New York, New York.
Cited most
Across all Koios Medical observations on file
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 820.184Device history record1
The complete Koios Medical file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
New York, New York
One Form 483 · 2021 · 2 observations
Latest: Form 483, May 13, 2021 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-05-13 | 483 Form 483 | New York, New York | 2 | $99 |
Investigators on these documents
FEI number 3010119782 · most recent document May 13, 2021
About Koios Medical, Inc
How many FDA Form 483s has Koios Medical, Inc received?
FDA Intel has 1 Form 483 on file for Koios Medical, Inc; the most recent is dated May 13, 2021.
When was Koios Medical, Inc last inspected by FDA?
The most recent FDA inspection document on file for Koios Medical, Inc is a Form 483 dated May 13, 2021, for the site in New York, New York.
What did FDA cite at Koios Medical, Inc?
The regulations cited most in the observations on file for Koios Medical, Inc are 21 CFR 803.17 (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 1 time; 21 CFR 820.184 (Device history record), 1 time.