Daiichi Sankyo Co., Ltd.
Form 483 issued July 9, 2021 · Iwaki, Japan
- Inspection
- Jul 5 – Jul 9, 2021
- Investigators
- Jun Liu· Thuy T. Nguyen
- Observations
- 2
- Pages
- 1
- FEI number
- 3002808054
In short: On July 9, 2021, FDA issued a Form 483 with 2 observations to Daiichi Sankyo Co., Ltd. in Iwaki, Fukushima (FEI 3002808054) after an inspection that ran Jul 5 – Jul 9, 2021. The investigators were Jun Liu and Thuy T. Nguyen. Most observations concern facilities & equipment and materials; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and materials account for 2 of 2 observations.
Most cited: 21 CFR 211.67 (1×) · 211.84 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment cleaning validations conducted to support the cleaning of equipment used in the production of drug…
- 02
Identity test of the RE sed in the manufacturing of the| rug substance (product contact) process…
This inspection in context
Jun Liu
5 documents · 2019–2024
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Japan.
The firmDaiichi Sankyo Co., Ltd. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Daiichi Sankyo Co., Ltd.?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and materials. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Daiichi Sankyo Co., Ltd.?
Jun Liu and Thuy T. Nguyen are named on this Form 483, for the inspection of Jul 5 – Jul 9, 2021. Each investigator has a profile showing what they cite most.
When was Daiichi Sankyo Co., Ltd. inspected by FDA?
The inspection ran Jul 5 – Jul 9, 2021, and the Form 483 is dated July 9, 2021.
How do I get the full Form 483 for Daiichi Sankyo Co., Ltd.?
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