Tokyo Chemical Industry Co., Ltd.
FDA inspection history in Fukaya, Japan, 2018 to 2025
- 2
- Form 483s
Every document, by year
- Form 483
2018: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at Fukaya, Japan.
- 2018The longest 483 on file: 3 observations over 2 pages at Fukaya, Japan.
- 2025One Form 483, at Fukaya, Japan.
Cited most
Across all Tokyo Chemical Industry Co. observations on file
- 21 CFR 211.160General requirements1
- 21 CFR 211.166Stability testing1
- 21 CFR 211.192Production record review1
- 21 CFR 211.204Returned drug products1
- 21 CFR 211.68Automatic, mechanical, and electronic equipment1
The complete Tokyo Chemical Industry Co. file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Fukaya, Japan
Two Form 483s · 2018 to 2025 · 5 observations
Latest: Form 483, May 16, 2025 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-05-16 | 483 Form 483 | Fukaya, Japan | 2 | $99 |
| 2018-10-19 | 483 Form 483 | Fukaya, Japan | 3 | $99 |
Investigators on these documents
FEI number 3002808353 · most recent document May 16, 2025
About Tokyo Chemical Industry Co., Ltd.
How many FDA Form 483s has Tokyo Chemical Industry Co., Ltd. received?
FDA Intel has 2 Form 483s on file for Tokyo Chemical Industry Co., Ltd.; the most recent is dated May 16, 2025.
When was Tokyo Chemical Industry Co., Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Tokyo Chemical Industry Co., Ltd. is a Form 483 dated May 16, 2025, for the site in Fukaya, Japan.
What did FDA cite at Tokyo Chemical Industry Co., Ltd.?
The regulations cited most in the observations on file for Tokyo Chemical Industry Co., Ltd. are 21 CFR 211.160 (General requirements), 1 time; 21 CFR 211.166 (Stability testing), 1 time; 21 CFR 211.192 (Production record review), 1 time.