UBE Corporation
FDA inspection history in Ube, Japan, 2015 to 2017
- 2
- Form 483s
Every document, by year
- Form 483
2015: one Form 483; 2017: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–17Two Form 483s, at Ube, Japan.
- 2017The longest 483 on file: 1 observation over 2 pages at Ube, Japan.
Cited most
Across all UBE observations on file
- 21 CFR 211.194Laboratory records2
- 21 CFR 211.68Automatic, mechanical, and electronic equipment2
- 21 CFR 211.160General requirements1
- 21 CFR 211.192Production record review1
The complete UBE 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
Ube, Japan
Two Form 483s · 2015 to 2017 · 1 observation
Latest: Form 483, Sep 28, 2017 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-09-28 | 483 Form 483 | Ube, Japan | 1 | $99 |
| 2015-01-28 | 483 Form 483 | Ube, Japan | — | $99 |
Investigators on these documents
FEI number 3003604942 · most recent document Sep 28, 2017
About UBE Corporation
How many FDA Form 483s has UBE Corporation received?
FDA Intel has 2 Form 483s on file for UBE Corporation; the most recent is dated Sep 28, 2017.
When was UBE Corporation last inspected by FDA?
The most recent FDA inspection document on file for UBE Corporation is a Form 483 dated Sep 28, 2017, for the site in Ube, Japan.
What did FDA cite at UBE Corporation?
The regulations cited most in the observations on file for UBE Corporation are 21 CFR 211.194 (Laboratory records), 2 times; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 2 times; 21 CFR 211.160 (General requirements), 1 time.