Kyowa Kirin Co., Ltd.
Form 483 issued December 14, 2022 · Takasaki-shi, Japan
- Inspection
- Nov 30 – Dec 14, 2022
- Investigator
- Cynthia Jim
- Observations
- 13
- Pages
- 7
- FEI number
- 3007588904
In short: On December 14, 2022, FDA issued a Form 483 with 13 observations to Kyowa Kirin Co., Ltd. in Takasaki-shi, Gunma (FEI 3007588904) after an inspection that ran Nov 30 – Dec 14, 2022. The investigator was Cynthia Jim. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Observations span 4 systems, led by facilities & equipment.
Most cited: 21 CFR 211.67 (2×) · 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
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 02
Samples taken of in-process materials for determination of conformance to…
- 03
Procedures for the cleaning and maintenance of equipment are deficient regarding the protection of clean equipment…
- 0421 CFR 11
Electronic signatures based on identification codes/passwords are used, but they do not meet the uniqueness and…
This inspection in context
Cynthia Jim
20 documents · 2012–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in North Carolina.
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 13 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. 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.?
Cynthia Jim is named on this Form 483, for the inspection of Nov 30 – Dec 14, 2022. Each investigator has a profile showing what they cite most.
When was Kyowa Kirin Co., Ltd. inspected by FDA?
The inspection ran Nov 30 – Dec 14, 2022, and the Form 483 is dated December 14, 2022.
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.