Takeda Pharmaceutical Company Limited
Form 483 issued November 6, 2023 · Hikari, Japan
- Inspection
- Nov 6, 2023
- Investigators
- Burnell M. Henry· Roger F. Zabinski
- Observations
- 5
- Pages
- 11
- FEI number
- 3004664162
In short: On November 6, 2023, FDA issued a Form 483 with 5 observations to Takeda Pharmaceutical Company Limited in Hikari, Yamaguchi (FEI 3004664162) after an inspection that ran Nov 6, 2023. The investigators were Burnell M. Henry and Roger F. Zabinski. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
3 of 5 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22 (2×) · 211.180 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Ow�, a Pfizer employee noticed that he was not able to locate file "87000003495677" in thellllllllllllllldata…
- 04
The firm's production batch record system i- and all original records relating to the quality, production…
This inspection in context
Burnell M. Henry
22 documents · 2012–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in North Carolina.
The firmTakeda Pharmaceutical Company Limited history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Takeda Pharmaceutical Company Limited?
FDA listed 5 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Takeda Pharmaceutical Company Limited?
Burnell M. Henry and Roger F. Zabinski are named on this Form 483, for the inspection of Nov 6, 2023. Each investigator has a profile showing what they cite most.
When was Takeda Pharmaceutical Company Limited inspected by FDA?
The inspection ran Nov 6, 2023, and the Form 483 is dated November 6, 2023.
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.