Hisamitsu Pharmaceutical Co., Inc.
FDA inspection history in Utsunomiya, 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 Utsunomiya, Japan.
Cited most
Across all Hisamitsu Pharmaceutical Co. observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.100(b)Written procedures; deviations1
- 21 CFR 211.165(e)Testing and release for distribution1
- 21 CFR 211.67(a)Equipment cleaning and maintenance1
The complete Hisamitsu Pharmaceutical Co. file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Utsunomiya, Japan
One Form 483 · 2019 · 5 observations
Latest: Form 483, Oct 11, 2019 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-10-11 | 483 Form 483 | Utsunomiya, Japan | 5 | $99 |
Investigators on these documents
FEI number 3008742780 · most recent document Oct 11, 2019
About Hisamitsu Pharmaceutical Co., Inc.
How many FDA Form 483s has Hisamitsu Pharmaceutical Co., Inc. received?
FDA Intel has 1 Form 483 on file for Hisamitsu Pharmaceutical Co., Inc.; the most recent is dated Oct 11, 2019.
When was Hisamitsu Pharmaceutical Co., Inc. last inspected by FDA?
The most recent FDA inspection document on file for Hisamitsu Pharmaceutical Co., Inc. is a Form 483 dated Oct 11, 2019, for the site in Utsunomiya, Japan.
What did FDA cite at Hisamitsu Pharmaceutical Co., Inc.?
The regulations cited most in the observations on file for Hisamitsu Pharmaceutical Co., Inc. are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.100(b) (Written procedures; deviations), 1 time; 21 CFR 211.165(e) (Testing and release for distribution), 1 time.