ASANUMA CORPORATION
Form 483 issued February 28, 2025 · SAGAMIHARA, Japan
- Inspection
- Feb 25 – Feb 28, 2025
- Investigator
- Matthew B. Casale
- Observations
- 3
- Pages
- 3
- FEI number
- 3010960168
In short: On February 28, 2025, FDA issued a Form 483 with 3 observations to ASANUMA CORPORATION in SAGAMIHARA, KANAGAWA (FEI 3010960168) after an inspection that ran Feb 25 – Feb 28, 2025. The investigator was Matthew B. Casale. Most observations concern materials and laboratory controls.
At a glance
Materials and laboratory controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Specific identification tests are not conducted on components that have been accepted based on the…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 03
Control procedures are not established which validate the performance of those manufacturing processes that may be…
This inspection in context
Matthew B. Casale
29 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Ohio.
The firmASANUMA CORPORATION history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.84(d)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ASANUMA CORPORATION?
FDA listed 3 observations on this Form 483, mostly about materials, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected ASANUMA CORPORATION?
Matthew B. Casale is named on this Form 483, for the inspection of Feb 25 – Feb 28, 2025. Each investigator has a profile showing what they cite most.
When was ASANUMA CORPORATION inspected by FDA?
The inspection ran Feb 25 – Feb 28, 2025, and the Form 483 is dated February 28, 2025.
How do I get the full Form 483 for ASANUMA 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.