Takeda Pharmaceutical Company Limited
Form 483 issued August 9, 2019 · Yodogawa-Ku, Japan
- Inspection
- Aug 1 – Aug 9, 2019
- Investigator
- Patric C. Klotzbuecher
- Observations
- 4
- Pages
- 5
- FEI number
- 3002808311
In short: On August 9, 2019, FDA issued a Form 483 with 4 observations to Takeda Pharmaceutical Company Limited in Yodogawa-Ku, Osaka (FEI 3002808311) after an inspection that ran Aug 1 – Aug 9, 2019. The investigator was Patric C. Klotzbuecher. Most observations concern production and laboratory controls.
At a glance
Production and laboratory controls account for 4 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 03
Manufacturer Laboratory records do not include complete data derived from all tests, examinations and assay necessary…
- 04
Deviations from written production and process control…
This inspection in context
Patric C. Klotzbuecher
13 documents · 2014–2019
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmTakeda Pharmaceutical Company Limited history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Takeda Pharmaceutical Company Limited?
FDA listed 4 observations on this Form 483, mostly about production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Takeda Pharmaceutical Company Limited?
Patric C. Klotzbuecher is named on this Form 483, for the inspection of Aug 1 – Aug 9, 2019. Each investigator has a profile showing what they cite most.
When was Takeda Pharmaceutical Company Limited inspected by FDA?
The inspection ran Aug 1 – Aug 9, 2019, and the Form 483 is dated August 9, 2019.
How do I get the full Form 483 for Takeda Pharmaceutical Company Limited?
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.