Hitachi Medical Systems America Inc.
Form 483 issued February 6, 2017 · Twinsburg, Ohio
- Inspection
- Jan 18 – Feb 6, 2017
- Investigator
- Benjamin Dastoli
- Observations
- 1
- Pages
- 3
- FEI number
- 1528028
In short: On February 6, 2017, FDA issued a Form 483 with 1 observation to Hitachi Medical Systems America Inc. in Twinsburg, Ohio (FEI 1528028) after an inspection that ran Jan 18 – Feb 6, 2017. The investigator was Benjamin Dastoli. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 820.198(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Complaint files are not…
This inspection in context
Benjamin Dastoli
12 documents · 2009–2023
Cites 820.75 (process validation) more than any other section. Most of their documents are for sites in Ohio.
The firmHitachi Medical Systems America Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.198(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hitachi Medical Systems America Inc.?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Hitachi Medical Systems America Inc.?
Benjamin Dastoli is named on this Form 483, for the inspection of Jan 18 – Feb 6, 2017. Each investigator has a profile showing what they cite most.
When was Hitachi Medical Systems America Inc. inspected by FDA?
The inspection ran Jan 18 – Feb 6, 2017, and the Form 483 is dated February 6, 2017.
How do I get the full Form 483 for Hitachi Medical Systems America 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.