Hitachi Chemical Diagnostics, Inc
Form 483 issued April 21, 2015 · Mountain View, California
- Inspection
- Apr 16 – Apr 21, 2015
- Investigator
- Paul M. Kawamoto
- Observations
- 1
- Pages
- 4
- FEI number
- 2936856
In short: On April 21, 2015, FDA issued a Form 483 with 1 observation to Hitachi Chemical Diagnostics, Inc in Mountain View, California (FEI 2936856) after an inspection that ran Apr 16 – Apr 21, 2015. The investigator was Paul M. Kawamoto. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 820.100(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
This inspection in context
Paul M. Kawamoto
7 documents · 2015–2021
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Washington.
The firmHitachi Chemical Diagnostics, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hitachi Chemical Diagnostics, Inc?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected Hitachi Chemical Diagnostics, Inc?
Paul M. Kawamoto is named on this Form 483, for the inspection of Apr 16 – Apr 21, 2015. Each investigator has a profile showing what they cite most.
When was Hitachi Chemical Diagnostics, Inc inspected by FDA?
The inspection ran Apr 16 – Apr 21, 2015, and the Form 483 is dated April 21, 2015.
How do I get the full Form 483 for Hitachi Chemical Diagnostics, Inc?
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.