Shiono Finesse, Ltd.
FDA inspection history in SAKAI, 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 SAKAI, Japan.
Cited most
Across all Shiono Finesse observations on file
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.166Stability testing1
- 21 CFR 211.170Reserve samples1
The complete Shiono Finesse file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
SAKAI, Japan
One Form 483 · 2018 · 8 observations
Latest: Form 483, Jun 8, 2018 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-06-08 | 483 Form 483 | SAKAI, Japan | 8 | $99 |
Investigators on these documents
FEI number 3005940219 · most recent document Jun 8, 2018
About Shiono Finesse, Ltd.
How many FDA Form 483s has Shiono Finesse, Ltd. received?
FDA Intel has 1 Form 483 on file for Shiono Finesse, Ltd.; the most recent is dated Jun 8, 2018.
When was Shiono Finesse, Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Shiono Finesse, Ltd. is a Form 483 dated Jun 8, 2018, for the site in SAKAI, Japan.
What did FDA cite at Shiono Finesse, Ltd.?
The regulations cited most in the observations on file for Shiono Finesse, Ltd. are 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times; 21 CFR 211.84 (Testing and approval or rejection of components, drug product containers, and closures), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time.