Chugai Pharma Manufacturing Co. Ltd. (CPMC)
Form 483 issued March 29, 2024 · TKY, Japan
- Inspection
- Mar 28 – Mar 29, 2024
- Observations
- 5
- Pages
- 4
- FEI number
- 3004109596
In short: On March 29, 2024, FDA issued a Form 483 with 5 observations to Chugai Pharma Manufacturing Co. Ltd. (CPMC) in TKY, Japan (FEI 3004109596) after an inspection that ran Mar 28 – Mar 29, 2024. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Facilities & equipment and production account for 4 of 5 observations.
Most cited: 21 CFR 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
is a risk of cross-contamination in your drug substance (DS) manufacturing operations in building Chugai Pharma…
- 02
A riate procedural controls have not been established to protect laboratory electronic data used for the…
- 03
Written production and process control procedures are not…
- 04
Standard operating procedures and protocols are not…
This inspection in context
Questions about this 483
What did FDA find at Chugai Pharma Manufacturing Co. Ltd. (CPMC)?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
When was Chugai Pharma Manufacturing Co. Ltd. (CPMC) inspected by FDA?
The inspection ran Mar 28 – Mar 29, 2024, and the Form 483 is dated March 29, 2024.
How do I get the full Form 483 for Chugai Pharma Manufacturing Co. Ltd. (CPMC)?
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.