Chugai Pharma Manufacturing Co., Ltd.
Form 483 issued September 26, 2019 · Utsunomiya, Japan
- Inspection
- Sep 17 – Sep 26, 2019
- Investigator
- Cheryl Clausen
- Observations
- 4
- Pages
- 6
- FEI number
- 3006942691
In short: On September 26, 2019, FDA issued a Form 483 with 4 observations to Chugai Pharma Manufacturing Co., Ltd. in Utsunomiya, TCG (FEI 3006942691) after an inspection that ran Sep 17 – Sep 26, 2019. The investigator was Cheryl Clausen. Most observations concern laboratory controls and facilities & equipment.
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 03
Control procedures are not established which monitor the output of those manufacturing processes that may be…
- 04
The quality control unit lacks authority to review production records to assure that no errors have…
This inspection in context
Cheryl Clausen
18 documents · 2016–2020
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in India.
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 211.194(a)
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 4 observations on this Form 483, mostly about laboratory controls, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Chugai Pharma Manufacturing Co., Ltd.?
Cheryl Clausen is named on this Form 483, for the inspection of Sep 17 – Sep 26, 2019. Each investigator has a profile showing what they cite most.
When was Chugai Pharma Manufacturing Co., Ltd. inspected by FDA?
The inspection ran Sep 17 – Sep 26, 2019, and the Form 483 is dated September 26, 2019.
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.