Chugai Pharma Manufacturing Co. Ltd. (CPMC)
FDA inspection history in TKY, Japan, 2017 to 2024
- 3
- Form 483s
Every document, by year
- Form 483
2017: one Form 483; 2021: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017One Form 483, at TKY, Japan.
- 2017The longest 483 on file: 8 observations over 4 pages at TKY, Japan.
- 2021One Form 483, at TKY, Japan.
- 2024One Form 483, at TKY, Japan.
Cited most
Across all Chugai Pharma Manufacturing Co. Ltd. (CPMC) observations on file
- 21 CFR 211.100Written procedures; deviations5
- 21 CFR 211.67Equipment cleaning and maintenance3
- 21 CFR 211.68Automatic, mechanical, and electronic equipment3
- 21 CFR 211.56Sanitation2
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures2
The complete Chugai Pharma Manufacturing Co. Ltd. (CPMC) file.
All 3 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
TKY, Japan
Three Form 483s · 2017 to 2024 · 19 observations
Latest: Form 483, Mar 29, 2024 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-03-29 | 483 Form 483 | TKY, Japan | 5 | $99 |
| 2021-08-23 | 483 Form 483 | TKY, Japan | 6 | $99 |
| 2017-09-27 | 483 Form 483 | TKY, Japan | 8 | $99 |
Investigators on these documents
FEI number 3004109596 · most recent document Mar 29, 2024
About Chugai Pharma Manufacturing Co. Ltd. (CPMC)
How many FDA Form 483s has Chugai Pharma Manufacturing Co. Ltd. (CPMC) received?
FDA Intel has 3 Form 483s on file for Chugai Pharma Manufacturing Co. Ltd. (CPMC); the most recent is dated Mar 29, 2024.
When was Chugai Pharma Manufacturing Co. Ltd. (CPMC) last inspected by FDA?
The most recent FDA inspection document on file for Chugai Pharma Manufacturing Co. Ltd. (CPMC) is a Form 483 dated Mar 29, 2024, for the site in TKY, Japan.
What did FDA cite at Chugai Pharma Manufacturing Co. Ltd. (CPMC)?
The regulations cited most in the observations on file for Chugai Pharma Manufacturing Co. Ltd. (CPMC) are 21 CFR 211.100 (Written procedures; deviations), 5 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 3 times; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 3 times.