UBE Corporation
Form 483 issued September 28, 2017 · Ube, Japan
- Inspection
- Sep 25 – Sep 28, 2017
- Investigator
- Marcus F. Yambot
- Observations
- 1
- Pages
- 2
- FEI number
- 3003604942
In short: On September 28, 2017, FDA issued a Form 483 with 1 observation to UBE Corporation in Ube, Yamaguchi (FEI 3003604942) after an inspection that ran Sep 25 – Sep 28, 2017. The investigator was Marcus F. Yambot. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68 (1×) · 211.194 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The Quality Unit failed to implement adequate systems and procedures for managing quality across different departments…
This inspection in context
Marcus F. Yambot
16 documents · 2009–2023
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in California.
The firmUBE Corporation history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at UBE Corporation?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected UBE Corporation?
Marcus F. Yambot is named on this Form 483, for the inspection of Sep 25 – Sep 28, 2017. Each investigator has a profile showing what they cite most.
When was UBE Corporation inspected by FDA?
The inspection ran Sep 25 – Sep 28, 2017, and the Form 483 is dated September 28, 2017.
How do I get the full Form 483 for UBE Corporation?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.