Chugai Pharma Manufacturing Co., Ltd.
Form 483 issued April 2, 2024 · Utsunomiya, Japan
- Inspection
- Mar 25 – Apr 2, 2024
- Investigator
- Christopher R. Czajka
- Observations
- 1
- Pages
- 2
- FEI number
- 3006942691
In short: On April 2, 2024, FDA issued a Form 483 with 1 observation to Chugai Pharma Manufacturing Co., Ltd. in Utsunomiya, Japan (FEI 3006942691) after an inspection that ran Mar 25 – Apr 2, 2024. The investigator was Christopher R. Czajka. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
This inspection in context
Christopher R. Czajka
37 documents · 2015–2025
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in California.
The firmChugai Pharma Manufacturing 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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Chugai Pharma Manufacturing Co., Ltd.?
FDA listed 1 observation on this Form 483, mostly about production. 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 Chugai Pharma Manufacturing Co., Ltd.?
Christopher R. Czajka is named on this Form 483, for the inspection of Mar 25 – Apr 2, 2024. Each investigator has a profile showing what they cite most.
When was Chugai Pharma Manufacturing Co., Ltd. inspected by FDA?
The inspection ran Mar 25 – Apr 2, 2024, and the Form 483 is dated April 2, 2024.
How do I get the full Form 483 for Chugai Pharma Manufacturing Co., Ltd.?
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