Otsuka Pharmaceutical Co., Ltd.
FDA inspection history in OMAGARI, Japan, 2019
- 1
- Form 483
Every document, by year
- Form 483
2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at OMAGARI, Japan.
Cited most
Across all Otsuka Pharmaceutical Co. observations on file
- 21 CFR 211.142Warehousing procedures1
- 21 CFR 211.192Production record review1
The complete Otsuka Pharmaceutical Co. file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
OMAGARI, Japan
One Form 483 · 2019 · 2 observations
Latest: Form 483, Feb 1, 2019 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-02-01 | 483 Form 483 | OMAGARI, Japan | 2 | $99 |
Investigators on these documents
FEI number 3003808559 · most recent document Feb 1, 2019
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 Feb 1, 2019.
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 Feb 1, 2019, for the site in OMAGARI, 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 211.142 (Warehousing procedures), 1 time; 21 CFR 211.192 (Production record review), 1 time.