Juzen Chemical Corporation
Form 483 issued March 9, 2018 · Toyama-city, Japan
- Inspection
- Mar 5 – Mar 9, 2018
- Investigator
- Saied A. Asbagh
- Observations
- 3
- Pages
- 2
- FEI number
- 3000225055
In short: On March 9, 2018, FDA issued a Form 483 with 3 observations to Juzen Chemical Corporation in Toyama-city, Toyama (FEI 3000225055) after an inspection that ran Mar 5 – Mar 9, 2018. The investigator was Saied A. Asbagh. Most observations concern facilities & equipment and quality system.
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Equip: ls are not cleaned at appropriate intervals to prevent contamination that would alter the safety…
- 02
The separate or defined areas and control systems necessary to prevent contamination…
- 03
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Saied A. Asbagh
12 documents · 2016–2024
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in California.
The firmJuzen Chemical Corporation history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Juzen Chemical Corporation?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Juzen Chemical Corporation?
Saied A. Asbagh is named on this Form 483, for the inspection of Mar 5 – Mar 9, 2018. Each investigator has a profile showing what they cite most.
When was Juzen Chemical Corporation inspected by FDA?
The inspection ran Mar 5 – Mar 9, 2018, and the Form 483 is dated March 9, 2018.
How do I get the full Form 483 for Juzen Chemical 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.