Chugai Pharma Manufacturing Co., Ltd.
Form 483 issued September 1, 2017 · Utsunomiya, Japan
- Inspection
- Aug 24 – Sep 1, 2017
- Investigators
- Aimee Cunningham· Marion Michaelis
- Observations
- 5
- Pages
- 2
- FEI number
- 3006942691
In short: On September 1, 2017, FDA issued a Form 483 with 5 observations to Chugai Pharma Manufacturing Co., Ltd. in Utsunomiya, TCG (FEI 3006942691) after an inspection that ran Aug 24 – Sep 1, 2017. The investigators were Aimee Cunningham and Marion Michaelis. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Smoke studies performed on filling linew in Building under static (December 7, 2015) and dynamic (August…
- 02
Quality assurance oversight is…
- 03
Deviations are not fully investigated or initiated within…
- 04
Validation of the electronic Manufacturing Execution System (MES) HITPHAMS and preparation of the Master Baich Record…
This inspection in context
Aimee Cunningham
2 documents · 2017–2019
Cites 211.113 (control of microbiological contamination) 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 5 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Chugai Pharma Manufacturing Co., Ltd.?
Aimee Cunningham and Marion Michaelis are named on this Form 483, for the inspection of Aug 24 – Sep 1, 2017. Each investigator has a profile showing what they cite most.
When was Chugai Pharma Manufacturing Co., Ltd. inspected by FDA?
The inspection ran Aug 24 – Sep 1, 2017, and the Form 483 is dated September 1, 2017.
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.