SUMITOMO OSAKA CEMENT CO., LTD.
FDA inspection history in KAIZUKA, Japan, 2023
- 1
- Form 483
Every document, by year
- Form 483
2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2023One Form 483, at KAIZUKA, Japan.
Cited most
Across all SUMITOMO OSAKA CEMENT CO. observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.67Equipment cleaning and maintenance1
- 21 CFR 211.68Automatic, mechanical, and electronic equipment1
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures1
The complete SUMITOMO OSAKA CEMENT CO. file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
KAIZUKA, Japan
One Form 483 · 2023 · 5 observations
Latest: Form 483, Oct 27, 2023 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-10-27 | 483 Form 483 | KAIZUKA, Japan | 5 | $99 |
FEI number 3003943727 · most recent document Oct 27, 2023
About SUMITOMO OSAKA CEMENT CO., LTD.
How many FDA Form 483s has SUMITOMO OSAKA CEMENT CO., LTD. received?
FDA Intel has 1 Form 483 on file for SUMITOMO OSAKA CEMENT CO., LTD.; the most recent is dated Oct 27, 2023.
When was SUMITOMO OSAKA CEMENT CO., LTD. last inspected by FDA?
The most recent FDA inspection document on file for SUMITOMO OSAKA CEMENT CO., LTD. is a Form 483 dated Oct 27, 2023, for the site in KAIZUKA, Japan.
What did FDA cite at SUMITOMO OSAKA CEMENT CO., LTD.?
The regulations cited most in the observations on file for SUMITOMO OSAKA CEMENT CO., LTD. are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.22 (Responsibilities of quality control unit), 1 time; 21 CFR 211.67 (Equipment cleaning and maintenance), 1 time.