Medynus Inc
Form 483 issued December 17, 2024 · Irvine, California
- Inspection
- Dec 16 – Dec 17, 2024
- Investigator
- Kevin N. Tran
- Observations
- 6
- Pages
- 5
- FEI number
- 3015426608
In short: On December 17, 2024, FDA issued a Form 483 with 6 observations to Medynus Inc in Irvine, California (FEI 3015426608) after an inspection that ran Dec 16 – Dec 17, 2024. The investigator was Kevin N. Tran. Most observations concern production & process controls and cAPA.
At a glance
Production & process controls and capa account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design validation…
- 02
The type and extent of control to be exercised over suppliers was not clearly…
- 03
Procedures for corrective and preventive action have…
- 04
EM PLOYEE(S) SIGNATURE Procedures for acceptance of incoming product have…
This inspection in context
Kevin N. Tran
7 documents · 2019–2025
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in California.
The firmMedynus Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(g)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Medynus Inc?
FDA listed 6 observations on this Form 483, mostly about production & process controls, cAPA and design controls. The opening words of each observation are shown on this page.
Who inspected Medynus Inc?
Kevin N. Tran is named on this Form 483, for the inspection of Dec 16 – Dec 17, 2024. Each investigator has a profile showing what they cite most.
When was Medynus Inc inspected by FDA?
The inspection ran Dec 16 – Dec 17, 2024, and the Form 483 is dated December 17, 2024.
How do I get the full Form 483 for Medynus 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.