Takeda Pharmaceutical Company Limited
Form 483 issued May 24, 2023 · Hikari, Japan
- Inspection
- May 18 – May 24, 2023
- Observations
- 7
- Pages
- 5
- FEI number
- 3004664162
In short: On May 24, 2023, FDA issued a Form 483 with 7 observations to Takeda Pharmaceutical Company Limited in Hikari, Yamaguchi (FEI 3004664162) after an inspection that ran May 18 – May 24, 2023. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Facilities & equipment and production account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Questions about this 483
What did FDA find at Takeda Pharmaceutical Company Limited?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
When was Takeda Pharmaceutical Company Limited inspected by FDA?
The inspection ran May 18 – May 24, 2023, and the Form 483 is dated May 24, 2023.
How do I get the full Form 483 for Takeda Pharmaceutical Company Limited?
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