Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
Form 483 issued September 10, 2019 · Tokushima, Japan
- Inspection
- Sep 2 – Sep 10, 2019
- Investigator
- Michael Y. Philopoulos
- Observations
- 1
- Pages
- 2
- FEI number
- 3002807834
In short: On September 10, 2019, FDA issued a Form 483 with 1 observation to Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. in Tokushima, TOKUSHIMA (FEI 3002807834) after an inspection that ran Sep 2 – Sep 10, 2019. The investigator was Michael Y. Philopoulos. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42 (1×) · 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The procedures, contfols, and/or locations used for environmental monitoring are lacking or not always adequate…
This inspection in context
Michael Y. Philopoulos
4 documents · 2014–2019
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Indiana.
The firmSecond Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.?
Michael Y. Philopoulos is named on this Form 483, for the inspection of Sep 2 – Sep 10, 2019. Each investigator has a profile showing what they cite most.
When was Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Sep 2 – Sep 10, 2019, and the Form 483 is dated September 10, 2019.
How do I get the full Form 483 for Second Tokushima Factory, Otsuka Pharmaceutical Co., 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.