Chugai Pharma Manufacturing Co., Ltd.
FDA inspection history in Utsunomiya, Japan, 2017 to 2024
- 4
- Form 483s
Every document, by year
- Form 483
2017: one Form 483; 2019: one Form 483; 2020: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–20Three Form 483s, at Utsunomiya, Japan.
- 2017The longest 483 on file: 5 observations over 2 pages at Utsunomiya, Japan.
- 2024One Form 483, at Utsunomiya, Japan.
Cited most
Across all Chugai Pharma Manufacturing Co. observations on file
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.68Automatic, mechanical, and electronic equipment2
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
- 21 CFR 211.160General requirements1
The complete Chugai Pharma Manufacturing Co. file.
All 4 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
Utsunomiya, Japan
Four Form 483s · 2017 to 2024 · 12 observations
Latest: Form 483, Apr 2, 2024 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-04-02 | 483 Form 483 | Utsunomiya, Japan | 1 | $99 |
| 2020-02-21 | 483 Form 483 | Utsunomiya, Japan | 2 | $99 |
| 2019-09-26 | 483 Form 483 | Utsunomiya, Japan | 4 | $99 |
| 2017-09-01 | 483 Form 483 | Utsunomiya, Japan | 5 | $99 |
Investigators on these documents
Aimee Cunningham (1)Cheryl Clausen (1)Christopher R. Czajka (1)Marion Michaelis (1)Zhihao Peter Qiu (1)
FEI number 3006942691 · most recent document Apr 2, 2024
About Chugai Pharma Manufacturing Co., Ltd.
How many FDA Form 483s has Chugai Pharma Manufacturing Co., Ltd. received?
FDA Intel has 4 Form 483s on file for Chugai Pharma Manufacturing Co., Ltd.; the most recent is dated Apr 2, 2024.
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 Apr 2, 2024, for the site in Utsunomiya, 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 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.22 (Responsibilities of quality control unit), 2 times; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 2 times.