Ajinomoto Company, Inc.
Form 483 issued February 21, 2025 · Kawasaki, Japan
- Inspection
- Feb 17 – Feb 21, 2025
- Investigators
- Apseege Jose E. Melendez· Matthew B. Casale· Vincent Thomas
- Observations
- 3
- Pages
- 11
- FEI number
- 3002806336
In short: On February 21, 2025, FDA issued a Form 483 with 3 observations to Ajinomoto Company, Inc. in Kawasaki, Kanagawa (FEI 3002806336) after an inspection that ran Feb 17 – Feb 21, 2025. The investigators were Apseege Jose E. Melendez, Matthew B. Casale and Vincent Thomas. 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 observationDashed: section inferred by FDA Intel and checked against the regulation text
- 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
Apseege Jose E. Melendez
1 document · 2025
Cites 211.110 (sampling and testing of in-process materials and drug products) more than any other section. Most of their documents are for sites in Japan.
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 211.84
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 materials, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected Ajinomoto Company, Inc.?
Apseege Jose E. Melendez, Matthew B. Casale and Vincent Thomas are 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.