Chugai Pharma Manufacturing Co., Ltd.
FDA inspection history in Fujieda, Japan, 2019 to 2025
- 2
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Fujieda, Japan.
- 2025One Form 483, at Fujieda, Japan.
- 2025The longest 483 on file: 2 observations over 2 pages at Fujieda, Japan.
Cited most
Across all Chugai Pharma Manufacturing Co. observations on file
- 21 CFR 211.160General requirements1
- 21 CFR 211.192Production record review1
The complete Chugai Pharma Manufacturing 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
Fujieda, Japan
Two Form 483s · 2019 to 2025 · 3 observations
Latest: Form 483, Jul 4, 2025 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-07-04 | 483 Form 483 | Fujieda, Japan | 2 | $99 |
| 2019-08-30 | 483 Form 483 | Fujieda, Japan | 1 | $99 |
Investigators on these documents
FEI number 3002806758 · most recent document Jul 4, 2025
About Chugai Pharma Manufacturing Co., Ltd.
How many FDA Form 483s has Chugai Pharma Manufacturing Co., Ltd. received?
FDA Intel has 2 Form 483s on file for Chugai Pharma Manufacturing Co., Ltd.; the most recent is dated Jul 4, 2025.
When was Chugai Pharma Manufacturing Co., Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Chugai Pharma Manufacturing Co., Ltd. is a Form 483 dated Jul 4, 2025, for the site in Fujieda, Japan.
What did FDA cite at Chugai Pharma Manufacturing Co., Ltd.?
The regulations cited most in the observations on file for Chugai Pharma Manufacturing Co., Ltd. are 21 CFR 211.160 (General requirements), 1 time; 21 CFR 211.192 (Production record review), 1 time.