Kyowa Kirin Co., Ltd.
Form 483 issued August 30, 2021 · Takasaki-shi, Japan
- Inspection
- Aug 24 – Aug 30, 2021
- Investigators
- Jacek Cieslak· Zhong Li
- Observations
- 7
- Pages
- 4
- FEI number
- 3007588904
In short: On August 30, 2021, FDA issued a Form 483 with 7 observations to Kyowa Kirin Co., Ltd. in Takasaki-shi, Gunma (FEI 3007588904) after an inspection that ran Aug 24 – Aug 30, 2021. The investigators were Jacek Cieslak and Zhong Li. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and production account for 6 of 7 observations.
Most cited: 21 CFR 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Your firm has not established adequate procedur: to protect the electronic data acqui systems and process…
- 03
Standard Operating procedures or work instructions are not…
- 04
There is a lack of assur: ur cleaning procedures, used for product-contact process equipment used to…
This inspection in context
Jacek Cieslak
6 documents · 2019–2023
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Japan.
The firmKyowa Kirin Co., Ltd. history
All 4 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 Kyowa Kirin Co., Ltd.?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment and production. 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 Kyowa Kirin Co., Ltd.?
Jacek Cieslak and Zhong Li are named on this Form 483, for the inspection of Aug 24 – Aug 30, 2021. Each investigator has a profile showing what they cite most.
When was Kyowa Kirin Co., Ltd. inspected by FDA?
The inspection ran Aug 24 – Aug 30, 2021, and the Form 483 is dated August 30, 2021.
How do I get the full Form 483 for Kyowa Kirin 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.