Ono Pharmaceutical Co., Ltd.
FDA inspection history in FUJINOMIYA, Japan, 2018
- 1
- Form 483
Every document, by year
- Form 483
2018: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at FUJINOMIYA, Japan.
Cited most
Across all Ono Pharmaceutical Co. observations on file
- 21 CFR 211.160General requirements1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.67Equipment cleaning and maintenance1
The complete Ono Pharmaceutical Co. file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
FUJINOMIYA, Japan
One Form 483 · 2018 · 3 observations
Latest: Form 483, Dec 21, 2018 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-12-21 | 483 Form 483 | FUJINOMIYA, Japan | 3 | $99 |
Investigators on these documents
FEI number 3002807805 · most recent document Dec 21, 2018
About Ono Pharmaceutical Co., Ltd.
How many FDA Form 483s has Ono Pharmaceutical Co., Ltd. received?
FDA Intel has 1 Form 483 on file for Ono Pharmaceutical Co., Ltd.; the most recent is dated Dec 21, 2018.
When was Ono Pharmaceutical Co., Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Ono Pharmaceutical Co., Ltd. is a Form 483 dated Dec 21, 2018, for the site in FUJINOMIYA, Japan.
What did FDA cite at Ono Pharmaceutical Co., Ltd.?
The regulations cited most in the observations on file for Ono Pharmaceutical Co., Ltd. are 21 CFR 211.160 (General requirements), 1 time; 21 CFR 211.22 (Responsibilities of quality control unit), 1 time; 21 CFR 211.67 (Equipment cleaning and maintenance), 1 time.