Daiichi Sankyo Co., Ltd.
Form 483 issued November 8, 2019 · Iwaki, Japan
- Inspection
- Nov 5 – Nov 8, 2019
- Investigators
- Jun Liu· Ralph M. Bernstein
- Observations
- 5
- Pages
- 2
- FEI number
- 3002808054
In short: On November 8, 2019, FDA issued a Form 483 with 5 observations to Daiichi Sankyo Co., Ltd. in Iwaki, Fukushima (FEI 3002808054) after an inspection that ran Nov 5 – Nov 8, 2019. The investigators were Jun Liu and Ralph M. Bernstein. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
3 of 5 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (3×) · 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your quality unit failed to…
- 02
Your firm failed to conduct environmental monitoring from the start of…
- 03
Your firm’s disinfectant efficacy study fails to demonstrate selected disinfectants are adequate…
- 04
The qualification of the DFZ-2033 Freezer for storage o…
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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Daiichi Sankyo Co., Ltd.?
FDA listed 5 observations on this Form 483, mostly about production and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Daiichi Sankyo Co., Ltd.?
Jun Liu and Ralph M. Bernstein are named on this Form 483, for the inspection of Nov 5 – Nov 8, 2019. Each investigator has a profile showing what they cite most.
When was Daiichi Sankyo Co., Ltd. inspected by FDA?
The inspection ran Nov 5 – Nov 8, 2019, and the Form 483 is dated November 8, 2019.
How do I get the full Form 483 for Daiichi Sankyo Co., Ltd.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.