Medynus Inc
FDA inspection history in Irvine, California, 2024
- 1
- Form 483
Every document, by year
- Form 483
2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2024One Form 483, at Irvine, California.
Cited most
Across all Medynus observations on file
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.198(a)Complaint files1
- 21 CFR 820.22Quality audit1
- 21 CFR 820.30(g)Design controls1
- 21 CFR 820.50(a)(2)Purchasing controls1
The complete Medynus file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Irvine, California
One Form 483 · 2024 · 6 observations
Latest: Form 483, Dec 17, 2024 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-12-17 | 483 Form 483 | Irvine, California | 6 | $99 |
Investigators on these documents
FEI number 3015426608 · most recent document Dec 17, 2024
About Medynus Inc
How many FDA Form 483s has Medynus Inc received?
FDA Intel has 1 Form 483 on file for Medynus Inc; the most recent is dated Dec 17, 2024.
When was Medynus Inc last inspected by FDA?
The most recent FDA inspection document on file for Medynus Inc is a Form 483 dated Dec 17, 2024, for the site in Irvine, California.
What did FDA cite at Medynus Inc?
The regulations cited most in the observations on file for Medynus Inc are 21 CFR 820.100(a) (Corrective and preventive action), 1 time; 21 CFR 820.198(a) (Complaint files), 1 time; 21 CFR 820.22 (Quality audit), 1 time.