Daiichi Sankyo Co., Ltd.
Form 483 issued December 22, 2023 · Iwaki, Japan
- Inspection
- Dec 18 – Dec 22, 2023
- Investigator
- Jolanna A. Norton
- Observations
- 2
- Pages
- 3
- FEI number
- 3002808054
In short: On December 22, 2023, FDA issued a Form 483 with 2 observations to Daiichi Sankyo Co., Ltd. in Iwaki, Fukushima (FEI 3002808054) after an inspection that ran Dec 18 – Dec 22, 2023. The investigator was Jolanna A. Norton. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and production account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.100(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
This inspection in context
Jolanna A. Norton
22 documents · 2017–2026
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in California.
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 211.192
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 quality system and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Daiichi Sankyo Co., Ltd.?
Jolanna A. Norton is named on this Form 483, for the inspection of Dec 18 – Dec 22, 2023. Each investigator has a profile showing what they cite most.
When was Daiichi Sankyo Co., Ltd. inspected by FDA?
The inspection ran Dec 18 – Dec 22, 2023, and the Form 483 is dated December 22, 2023.
How do I get the full Form 483 for Daiichi Sankyo Co., Ltd.?
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