Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
FDA inspection history in Tokushima, Japan, 2019 to 2024
- 2
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Tokushima, Japan.
- 2024One Form 483, at Tokushima, Japan.
- 2024The longest 483 on file: 5 observations over 4 pages at Tokushima, Japan.
Cited most
Across all Second Tokushima Factory, Otsuka Pharmaceutical Co. observations on file
- 21 CFR 211.42Design and construction features2
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.160(a)General requirements1
- 21 CFR 211.192Production record review1
- 21 CFR 211.67(a)Equipment cleaning and maintenance1
The complete Second Tokushima Factory, 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
Tokushima, Japan
Two Form 483s · 2019 to 2024 · 6 observations
Latest: Form 483, Mar 22, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-03-22 | 483 Form 483 | Tokushima, Japan | 5 | $99 |
| 2019-09-10 | 483 Form 483 | Tokushima, Japan | 1 | $99 |
Investigators on these documents
FEI number 3002807834 · most recent document Mar 22, 2024
About Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
How many FDA Form 483s has Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. received?
FDA Intel has 2 Form 483s on file for Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.; the most recent is dated Mar 22, 2024.
When was Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. is a Form 483 dated Mar 22, 2024, for the site in Tokushima, Japan.
What did FDA cite at Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.?
The regulations cited most in the observations on file for Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. are 21 CFR 211.42 (Design and construction features), 2 times; 21 CFR 211.113 (Control of microbiological contamination), 1 time; 21 CFR 211.160(a) (General requirements), 1 time.