Daiichi Sankyo Co., Ltd.
FDA inspection history in Iwaki, Japan, 2019 to 2023
- 3
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2021: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–23Three Form 483s, at Iwaki, Japan.
- 2019The longest 483 on file: 5 observations over 2 pages at Iwaki, Japan.
Cited most
Across all Daiichi Sankyo Co. observations on file
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.192Production record review1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.67Equipment cleaning and maintenance1
The complete Daiichi Sankyo Co. 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
Iwaki, Japan
Three Form 483s · 2019 to 2023 · 9 observations
Latest: Form 483, Dec 22, 2023 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-12-22 | 483 Form 483 | Iwaki, Japan | 2 | $99 |
| 2021-07-09 | 483 Form 483 | Iwaki, Japan | 2 | $99 |
| 2019-11-08 | 483 Form 483 | Iwaki, Japan | 5 | $99 |
Investigators on these documents
Jun Liu (2)Jolanna A. Norton (1)Ralph M. Bernstein (1)Thuy T. Nguyen (1)
FEI number 3002808054 · most recent document Dec 22, 2023
About Daiichi Sankyo Co., Ltd.
How many FDA Form 483s has Daiichi Sankyo Co., Ltd. received?
FDA Intel has 3 Form 483s on file for Daiichi Sankyo Co., Ltd.; the most recent is dated Dec 22, 2023.
When was Daiichi Sankyo Co., Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Daiichi Sankyo Co., Ltd. is a Form 483 dated Dec 22, 2023, for the site in Iwaki, Japan.
What did FDA cite at Daiichi Sankyo Co., Ltd.?
The regulations cited most in the observations on file for Daiichi Sankyo Co., Ltd. are 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.100(a) (Written procedures; deviations), 1 time; 21 CFR 211.192 (Production record review), 1 time.