Takeda Pharmaceutical Company Limited
Form 483 issued September 14, 2010 · Yodogawa-Ku, Japan
- Inspection
- Sep 6 – Sep 14, 2010
- Observations
- 2
- Pages
- 2
- FEI number
- 3002808311
In short: On September 14, 2010, FDA issued a Form 483 with 2 observations to Takeda Pharmaceutical Company Limited in Yodogawa-Ku, Osaka (FEI 3002808311) after an inspection that ran Sep 6 – Sep 14, 2010. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.113 (1×) · 211.42 (1×)
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…
- 02
Aseptic processing areas are deficient regarding the system…
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 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.
When was Takeda Pharmaceutical Company Limited inspected by FDA?
The inspection ran Sep 6 – Sep 14, 2010, and the Form 483 is dated September 14, 2010.
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.