Daizo Corporation
Form 483 issued November 6, 2023 · Kyoto, Japan
- Inspection
- Oct 30 – Nov 6, 2023
- Investigator
- Seneca Toms
- Observations
- 3
- Pages
- 2
- FEI number
- 3008470621
In short: On November 6, 2023, FDA issued a Form 483 with 3 observations to Daizo Corporation in Kyoto, Kyoto (FEI 3008470621) after an inspection that ran Oct 30 – Nov 6, 2023. The investigator was Seneca Toms. Most observations concern laboratory controls and facilities & equipment.
At a glance
2 of 3 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory records are deficient in that they do not include a complete record of all…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure…
This inspection in context
Seneca Toms
17 documents · 2013–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in North Carolina.
The firmDaizo Corporation history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.194(a)(4)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Daizo Corporation?
FDA listed 3 observations on this Form 483, mostly about laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Daizo Corporation?
Seneca Toms is named on this Form 483, for the inspection of Oct 30 – Nov 6, 2023. Each investigator has a profile showing what they cite most.
When was Daizo Corporation inspected by FDA?
The inspection ran Oct 30 – Nov 6, 2023, and the Form 483 is dated November 6, 2023.
How do I get the full Form 483 for Daizo Corporation?
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.