Otsuka Pharmaceutical Co., Ltd.
FDA inspection history in Tokushima, Japan, 2016
- 1
- Form 483
Every document, by year
- Form 483
2016: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One Form 483, at Tokushima, Japan.
Cited most
Across all Otsuka Pharmaceutical Co. observations on file
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.68Automatic, mechanical, and electronic equipment2
- 21 CFR 211.42Design and construction features1
The complete Otsuka Pharmaceutical Co. file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Tokushima, Japan
One Form 483 · 2016 · 5 observations
Latest: Form 483, Apr 15, 2016 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2016-04-15 | 483 Form 483 | Tokushima, Japan | 5 | $99 |
Investigators on these documents
FEI number 3002809299 · most recent document Apr 15, 2016
About Otsuka Pharmaceutical Co., Ltd.
How many FDA Form 483s has Otsuka Pharmaceutical Co., Ltd. received?
FDA Intel has 1 Form 483 on file for Otsuka Pharmaceutical Co., Ltd.; the most recent is dated Apr 15, 2016.
When was Otsuka Pharmaceutical Co., Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Otsuka Pharmaceutical Co., Ltd. is a Form 483 dated Apr 15, 2016, for the site in Tokushima, Japan.
What did FDA cite at Otsuka Pharmaceutical Co., Ltd.?
The regulations cited most in the observations on file for Otsuka Pharmaceutical Co., Ltd. are 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 2 times; 21 CFR 211.42 (Design and construction features), 1 time.