Okami Medical Inc.
FDA inspection history in Aliso Viejo, 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 Aliso Viejo, California.
Cited most
Across all Okami Medical observations on file
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.184Device history record1
- 21 CFR 820.198(a)Complaint files1
- 21 CFR 820.30(g)Design controls1
- 21 CFR 820.40Document controls1
The complete Okami Medical file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Aliso Viejo, California
One Form 483 · 2024 · 7 observations
Latest: Form 483, Dec 4, 2024 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-12-04 | 483 Form 483 | Aliso Viejo, California | 7 | $99 |
Investigators on these documents
FEI number 3016444913 · most recent document Dec 4, 2024
About Okami Medical Inc.
How many FDA Form 483s has Okami Medical Inc. received?
FDA Intel has 1 Form 483 on file for Okami Medical Inc.; the most recent is dated Dec 4, 2024.
When was Okami Medical Inc. last inspected by FDA?
The most recent FDA inspection document on file for Okami Medical Inc. is a Form 483 dated Dec 4, 2024, for the site in Aliso Viejo, California.
What did FDA cite at Okami Medical Inc.?
The regulations cited most in the observations on file for Okami Medical Inc. are 21 CFR 820.100(a) (Corrective and preventive action), 1 time; 21 CFR 820.184 (Device history record), 1 time; 21 CFR 820.198(a) (Complaint files), 1 time.