Takeda Pharmaceutical Company Limit ed
Form 483 issued November 6, 2023 · Hikari, Japan
- Inspection
- Oct 25 – Nov 6, 2023
- Investigators
- David J. Gomes· Michele Perry Williams
- Observations
- 4
- Pages
- 2
- FEI number
- 3004664
In short: On November 6, 2023, FDA issued a Form 483 with 4 observations to Takeda Pharmaceutical Company Limit ed in Hikari, Japan (FEI 3004664) after an inspection that ran Oct 25 – Nov 6, 2023. The investigators were David J. Gomes and Michele Perry Williams. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 3 of 4 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records are not made of investigations into unexplained discrepancies and the failure of a batch…
- 02
There is a failure to thoroughly review any unexplained discrepancy and/or the failure of a batch…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Each batch of drug product required to be free of objectionable microorganisms is not tested…
This inspection in context
David J. Gomes
3 documents · 2017–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Italy.
The firmTakeda Pharmaceutical Company Limit ed history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Takeda Pharmaceutical Company Limit ed?
FDA listed 4 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Takeda Pharmaceutical Company Limit ed?
David J. Gomes and Michele Perry Williams are named on this Form 483, for the inspection of Oct 25 – Nov 6, 2023. Each investigator has a profile showing what they cite most.
When was Takeda Pharmaceutical Company Limit ed inspected by FDA?
The inspection ran Oct 25 – Nov 6, 2023, and the Form 483 is dated November 6, 2023.
How do I get the full Form 483 for Takeda Pharmaceutical Company Limit ed?
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.