Chugai Pharma Manufacturing Co., Ltd.
Form 483 issued February 21, 2020 · Utsunomiya, Japan
- Inspection
- Feb 13 – Feb 21, 2020
- Investigator
- Zhihao Peter Qiu
- Observations
- 2
- Pages
- 1
- FEI number
- 3006942691
In short: On February 21, 2020, FDA issued a Form 483 with 2 observations to Chugai Pharma Manufacturing Co., Ltd. in Utsunomiya, TCG (FEI 3006942691) after an inspection that ran Feb 13 – Feb 21, 2020. The investigator was Zhihao Peter Qiu. Most observations concern production and laboratory controls.
At a glance
Production and laboratory controls account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological…
- 02
Test methods are inadequately…
This inspection in context
Zhihao Peter Qiu
5 documents · 2013–2021
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Japan.
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
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 production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Chugai Pharma Manufacturing Co., Ltd.?
Zhihao Peter Qiu is named on this Form 483, for the inspection of Feb 13 – Feb 21, 2020. Each investigator has a profile showing what they cite most.
When was Chugai Pharma Manufacturing Co., Ltd. inspected by FDA?
The inspection ran Feb 13 – Feb 21, 2020, and the Form 483 is dated February 21, 2020.
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.