Takeda Ireland Ltd.
Form 483 issued February 4, 2022 · Dublin, Ireland
- Inspection
- Jan 31 – Feb 4, 2022
- Observations
- 6
- Pages
- 4
- FEI number
- 3006687027
In short: On February 4, 2022, FDA issued a Form 483 with 6 observations to Takeda Ireland Ltd. in Dublin, Ireland (FEI 3006687027) after an inspection that ran Jan 31 – Feb 4, 2022. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into unexplained discrepancies do not always include…
- 02
Certificates of testing of containers and closures are accepted in lieu of testing without establishing the…
- 03
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 04
The written stability program does not assure testing of the drug product in the same container-closure…
This inspection in context
Questions about this 483
What did FDA find at Takeda Ireland Ltd.?
FDA listed 6 observations on this Form 483, mostly about quality system, laboratory controls and materials. The opening words of each observation are shown on this page.
When was Takeda Ireland Ltd. inspected by FDA?
The inspection ran Jan 31 – Feb 4, 2022, and the Form 483 is dated February 4, 2022.
How do I get the full Form 483 for Takeda Ireland Ltd.?
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.