Kyowa Kirin Co., Ltd.
Form 483 issued December 11, 2018 · Takasaki-shi, Japan
- Inspection
- Dec 3 – Dec 11, 2018
- Investigator
- Dennis Cantellops
- Observations
- 6
- Pages
- 4
- FEI number
- 3007588904
In short: On December 11, 2018, FDA issued a Form 483 with 6 observations to Kyowa Kirin Co., Ltd. in Takasaki-shi, Gunma (FEI 3007588904) after an inspection that ran Dec 3 – Dec 11, 2018. The investigator was Dennis Cantellops. 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 4 of 6 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
(Quality System) The responsibilities and procedures applicable to the quality control unit…
- 02
(Production System) Procedures designed to prevent microbiological contamination of drug substance purporting to be low…
- 03
(Laboratory Control System) Laboratory controls do not include the establishment of scientifically sound and appropriate test…
- 04
(Material System) Procedures for the cleaning and maintenance of equipment are deficient regarding assignment of responsibility…
This inspection in context
Dennis Cantellops
10 documents · 2015–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kyowa Kirin Co., Ltd.?
FDA listed 6 observations on this Form 483, mostly about quality system, production and facilities & equipment. 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 Kyowa Kirin Co., Ltd.?
Dennis Cantellops is named on this Form 483, for the inspection of Dec 3 – Dec 11, 2018. Each investigator has a profile showing what they cite most.
When was Kyowa Kirin Co., Ltd. inspected by FDA?
The inspection ran Dec 3 – Dec 11, 2018, and the Form 483 is dated December 11, 2018.
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.