Chugai Pharma Manufacturing Co., Ltd.
Form 483 issued July 4, 2025 · Fujieda, Japan
- Inspection
- Jun 30 – Jul 4, 2025
- Investigator
- Chad W. Rice
- Observations
- 2
- Pages
- 2
- FEI number
- 3002806758
In short: On July 4, 2025, FDA issued a Form 483 with 2 observations to Chugai Pharma Manufacturing Co., Ltd. in Fujieda, SZO (FEI 3002806758) after an inspection that ran Jun 30 – Jul 4, 2025. The investigator was Chad W. Rice. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Established test procedures are…
This inspection in context
Chad W. Rice
8 documents · 2023–2026
Cites 211.113(a) (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmChugai Pharma Manufacturing Co., Ltd. history
All 2 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 Chugai Pharma Manufacturing Co., Ltd.?
FDA listed 2 observations on this Form 483, mostly about quality system and laboratory controls. 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 Chugai Pharma Manufacturing Co., Ltd.?
Chad W. Rice is named on this Form 483, for the inspection of Jun 30 – Jul 4, 2025. Each investigator has a profile showing what they cite most.
When was Chugai Pharma Manufacturing Co., Ltd. inspected by FDA?
The inspection ran Jun 30 – Jul 4, 2025, and the Form 483 is dated July 4, 2025.
How do I get the full Form 483 for Chugai Pharma Manufacturing 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.