UBE Corporation
Form 483 issued January 28, 2015 · Ube, Japan
- Investigator
- Orrance J. Slayton
- Observations
- 3
- Pages
- 2
- FEI number
- 3003604942
In short: On January 28, 2015, FDA issued a Form 483 with 3 observations to UBE Corporation in Ube, Yamaguchi (FEI 3003604942). The investigator was Orrance J. Slayton. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
2 of 3 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm's OOS procedure, SOP #DQZ-A 1002014, does not include actions that ensure…
- 02
Your firm’s records of laboratory testing do not include complete records of results, the review of…
- 03
Observation 3: scanned text, readable in the full document.
This inspection in context
Orrance J. Slayton
1 document · 2015
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Japan.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at UBE Corporation?
FDA listed 3 observations on this Form 483, mostly about laboratory controls and quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected UBE Corporation?
Orrance J. Slayton is named on this Form 483. Each investigator has a profile showing what they cite most.
When was UBE Corporation inspected by FDA?
This Form 483 is dated January 28, 2015.
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.