Chugai Pharma Manufacturing Co. Ltd. (CPMC)
Form 483 issued September 27, 2017 · TKY, Japan
- Inspection
- Sep 19 – Sep 27, 2017
- Investigators
- Maxwell Van Tassell· Se We Bo Chi
- Observations
- 8
- Pages
- 4
- FEI number
- 3004109596
In short: On September 27, 2017, FDA issued a Form 483 with 8 observations to Chugai Pharma Manufacturing Co. Ltd. (CPMC) in TKY, Japan (FEI 3004109596) after an inspection that ran Sep 19 – Sep 27, 2017. The investigators were Maxwell Van Tassell and Se We Bo Chi. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and facilities & equipment account for 6 of 8 observations.
Most cited: 21 CFR 211.100 (2×) · 211.84 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Multiple deviations are not resolved in a timely manner in…
- 02
Raw materials are approved by the Quality Assurance group for use in manufacturing prior to the…
- 03
Standard Operation Procedures (SOPs) are deficient…
- 04
Equipment cleaning verification and…
This inspection in context
Maxwell Van Tassell
4 documents · 2017–2019
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Japan.
The firmChugai Pharma Manufacturing Co. Ltd. (CPMC) history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Chugai Pharma Manufacturing Co. Ltd. (CPMC)?
FDA listed 8 observations on this Form 483, mostly about production, facilities & equipment and materials. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Chugai Pharma Manufacturing Co. Ltd. (CPMC)?
Maxwell Van Tassell and Se We Bo Chi are named on this Form 483, for the inspection of Sep 19 – Sep 27, 2017. Each investigator has a profile showing what they cite most.
When was Chugai Pharma Manufacturing Co. Ltd. (CPMC) inspected by FDA?
The inspection ran Sep 19 – Sep 27, 2017, and the Form 483 is dated September 27, 2017.
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.