Takeda Pharmaceutical Company Limited
Form 483 issued November 26, 2019 · Hikari, Japan
- Inspection
- Nov 18 – Nov 26, 2019
- Investigators
- Ileana Barreto-Pettit· Steven M. Weinman
- Observations
- 7
- Pages
- 7
- FEI number
- 3004664162
In short: On November 26, 2019, FDA issued a Form 483 with 7 observations to Takeda Pharmaceutical Company Limited in Hikari, Yamaguchi (FEI 3004664162) after an inspection that ran Nov 18 – Nov 26, 2019. The investigators were Ileana Barreto-Pettit and Steven M. Weinman. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Investigations of a failure of a batch or any of its components to meet any of…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
This inspection in context
Ileana Barreto-Pettit
25 documents · 2001–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Florida.
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 211.113(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 7 observations on this Form 483, mostly about quality system, production and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Takeda Pharmaceutical Company Limited?
Ileana Barreto-Pettit and Steven M. Weinman are named on this Form 483, for the inspection of Nov 18 – Nov 26, 2019. Each investigator has a profile showing what they cite most.
When was Takeda Pharmaceutical Company Limited inspected by FDA?
The inspection ran Nov 18 – Nov 26, 2019, and the Form 483 is dated November 26, 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.