Okami Medical Inc.
Form 483 issued December 4, 2024 · Aliso Viejo, California
- Inspection
- Nov 18 – Dec 4, 2024
- Investigators
- Alexandria L. Capuano· Scott D. Stevens
- Observations
- 7
- Pages
- 6
- FEI number
- 3016444913
In short: On December 4, 2024, FDA issued a Form 483 with 7 observations to Okami Medical Inc. in Aliso Viejo, California (FEI 3016444913) after an inspection that ran Nov 18 – Dec 4, 2024. The investigators were Alexandria L. Capuano and Scott D. Stevens. Most observations concern cAPA and records & documents.
At a glance
CAPA and records & documents account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Design validation did not ensure the device conforms to defined user…
- 02
Software used as part of production has not been adequately validated for its intended use according…
- 03
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 04
Procedures for corrective and preventive action have…
This inspection in context
Alexandria L. Capuano
6 documents · 2022–2026
Cites 820.198 (complaint files) more than any other section. Most of their documents are for sites in California.
The firmOkami Medical 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 Okami Medical Inc.?
FDA listed 7 observations on this Form 483, mostly about cAPA, records & documents and design controls. The opening words of each observation are shown on this page.
Who inspected Okami Medical Inc.?
Alexandria L. Capuano and Scott D. Stevens are named on this Form 483, for the inspection of Nov 18 – Dec 4, 2024. Each investigator has a profile showing what they cite most.
When was Okami Medical Inc. inspected by FDA?
The inspection ran Nov 18 – Dec 4, 2024, and the Form 483 is dated December 4, 2024.
How do I get the full Form 483 for Okami 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.