Takeda Pharmaceutical Company Limited
Form 483 issued September 18, 2015 · Yodogawa-Ku, Japan
- Observations
- 2
- Pages
- 2
- FEI number
- 3002808311
In short: On September 18, 2015, FDA issued a Form 483 with 2 observations to Takeda Pharmaceutical Company Limited in Yodogawa-Ku, Osaka (FEI 3002808311). Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
Laboratory controls and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.194 (1×) · 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Questions about this 483
What did FDA find at Takeda Pharmaceutical Company Limited?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and quality system. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
When was Takeda Pharmaceutical Company Limited inspected by FDA?
This Form 483 is dated September 18, 2015.
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.