Koios Medical, Inc
Form 483 issued May 13, 2021 · New York, New York
- Inspection
- Mar 17 – May 13, 2021
- Investigator
- Kwong P. Lee
- Observations
- 2
- Pages
- 3
- FEI number
- 3010119782
In short: On May 13, 2021, FDA issued a Form 483 with 2 observations to Koios Medical, Inc in New York, New York (FEI 3010119782) after an inspection that ran Mar 17 – May 13, 2021. The investigator was Kwong P. Lee. Most observations concern records & documents and cAPA; the most-cited regulation is 21 CFR 820.184 (device history record).
At a glance
Records & documents and capa account for 2 of 2 observations.
Most cited: 21 CFR 820.184 (1×) · 803.17 (1×)
What FDA observed
Preview: the opening words of each observation- 01
A device history record has…
- 02
Written MDR procedures have…
This inspection in context
Kwong P. Lee
12 documents · 2015–2026
Cites 820.30(c) (design controls) more than any other section. Most of their documents are for sites in New York.
The firmKoios Medical, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.184
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Koios Medical, Inc?
FDA listed 2 observations on this Form 483, mostly about records & documents and cAPA. The most-cited regulation is 21 CFR 820.184 (device history record). The opening words of each observation are shown on this page.
Who inspected Koios Medical, Inc?
Kwong P. Lee is named on this Form 483, for the inspection of Mar 17 – May 13, 2021. Each investigator has a profile showing what they cite most.
When was Koios Medical, Inc inspected by FDA?
The inspection ran Mar 17 – May 13, 2021, and the Form 483 is dated May 13, 2021.
How do I get the full Form 483 for Koios 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.