Tokyo Chemical Industry Co., Ltd.
Form 483 issued May 16, 2025 · Fukaya, Japan
- Inspection
- May 12 – May 16, 2025
- Investigator
- Monica E. Murie
- Observations
- 2
- Pages
- 3
- FEI number
- 3002808353
In short: On May 16, 2025, FDA issued a Form 483 with 2 observations to Tokyo Chemical Industry Co., Ltd. in Fukaya, Saitama (FEI 3002808353) after an inspection that ran May 12 – May 16, 2025. The investigator was Monica E. Murie. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.166 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory testing and investigation procedures fail to thoroughly review, document, and provide scientifically sound and appropriate…
- 02
Stability storage conditions are not maintained throughout the lifetime of API included…
This inspection in context
Monica E. Murie
11 documents · 2022–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Missouri.
The firmTokyo Chemical Industry Co., Ltd. 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 Tokyo Chemical Industry Co., Ltd.?
FDA listed 2 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Tokyo Chemical Industry Co., Ltd.?
Monica E. Murie is named on this Form 483, for the inspection of May 12 – May 16, 2025. Each investigator has a profile showing what they cite most.
When was Tokyo Chemical Industry Co., Ltd. inspected by FDA?
The inspection ran May 12 – May 16, 2025, and the Form 483 is dated May 16, 2025.
How do I get the full Form 483 for Tokyo Chemical Industry Co., Ltd.?
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.