Otsuka Pharmaceutical Co Ltd.
FDA inspection history in KONIU, Japan, 2019 to 2025
- 2
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at KONIU, Japan.
- 2019The longest 483 on file: 7 observations over 13 pages at KONIU, Japan.
- 2025One Form 483, at KONIU, Japan.
Cited most
Across all Otsuka Pharmaceutical Co observations on file
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.113(b)Control of microbiological contamination1
- 21 CFR 211.160(b)General requirements1
- 21 CFR 211.170(b)Reserve samples1
- 21 CFR 211.186(a)Master production and control records1
The complete Otsuka Pharmaceutical Co file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
KONIU, Japan
Two Form 483s · 2019 to 2025 · 11 observations
Latest: Form 483, Jun 17, 2025 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-06-17 | 483 Form 483 | KONIU, Japan | 4 | $99 |
| 2019-10-22 | 483 Form 483 | KONIU, Japan | 7 | $99 |
Investigators on these documents
FEI number 3004810250 · most recent document Jun 17, 2025
About Otsuka Pharmaceutical Co Ltd.
How many FDA Form 483s has Otsuka Pharmaceutical Co Ltd. received?
FDA Intel has 2 Form 483s on file for Otsuka Pharmaceutical Co Ltd.; the most recent is dated Jun 17, 2025.
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 Jun 17, 2025, for the site in KONIU, 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 211.100(a) (Written procedures; deviations), 1 time; 21 CFR 211.113(b) (Control of microbiological contamination), 1 time; 21 CFR 211.160(b) (General requirements), 1 time.