Kyowa Kirin Co., Ltd.
Form 483 issued October 4, 2019 · Takasaki-shi, Japan
- Inspection
- Sep 25 – Oct 4, 2019
- Investigators
- Chen Sun· Madushini Dharmasena
- Observations
- 4
- Pages
- 1
- FEI number
- 3007588904
In short: On October 4, 2019, FDA issued a Form 483 with 4 observations to Kyowa Kirin Co., Ltd. in Takasaki-shi, Gunma (FEI 3007588904) after an inspection that ran Sep 25 – Oct 4, 2019. The investigators were Chen Sun and Madushini Dharmasena. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and facilities & equipment account for 3 of 4 observations.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Testing of critical materials…
- 02
The facility cleaning is documented in a room logbook only with the date and time at…
- 03
Bioburden limit of | CFU/10 mLis not appropriate for the), bioreactor sterile hold time validation study…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Chen Sun
3 documents · 2019–2022
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in France.
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 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kyowa Kirin Co., Ltd.?
FDA listed 4 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Kyowa Kirin Co., Ltd.?
Chen Sun and Madushini Dharmasena are named on this Form 483, for the inspection of Sep 25 – Oct 4, 2019. Each investigator has a profile showing what they cite most.
When was Kyowa Kirin Co., Ltd. inspected by FDA?
The inspection ran Sep 25 – Oct 4, 2019, and the Form 483 is dated October 4, 2019.
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.