Ajinomoto Company, Inc.
Form 483 issued February 21, 2025 · Kawasaki -City. Kanagawa, Japan
- Inspection
- Feb 17 – Feb 21, 2025
- Investigator
- Matthew B. Casale
- Observations
- 3
- Pages
- 3
- FEI number
- 3002806336
In short: On February 21, 2025, FDA issued a Form 483 with 3 observations to Ajinomoto Company, Inc. in Kawasaki -City. Kanagawa, Japan (FEI 3002806336) after an inspection that ran Feb 17 – Feb 21, 2025. The investigator was Matthew B. Casale. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Five out of five investigations into production deviations and laboratory out -of -specification results reviewed did…
- 02
The laboratory sample preparation worksheets used for preparation of all samples in the laboratory do not…
- 03
There is no data to support that the (b)used in the construction of production tanks, including…
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 firmAjinomoto Company, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ajinomoto Company, Inc.?
FDA listed 3 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Ajinomoto Company, Inc.?
Matthew B. Casale is named on this Form 483, for the inspection of Feb 17 – Feb 21, 2025. Each investigator has a profile showing what they cite most.
When was Ajinomoto Company, Inc. inspected by FDA?
The inspection ran Feb 17 – Feb 21, 2025, and the Form 483 is dated February 21, 2025.
How do I get the full Form 483 for Ajinomoto Company, 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.