Fujifilm Medical Systems U.S.A., Inc.
Form 483 issued July 2, 2019 · Wayne, New Jersey
- Inspection
- Jun 12 – Jul 2, 2019
- Investigator
- William R. Chang
- Observations
- 1
- Pages
- 3
- FEI number
- 2431293
In short: On July 2, 2019, FDA issued a Form 483 with 1 observation to Fujifilm Medical Systems U.S.A., Inc. in Wayne, New Jersey (FEI 2431293) after an inspection that ran Jun 12 – Jul 2, 2019. The investigator was William R. Chang. 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(e) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Records of complaint investigations do…
This inspection in context
William R. Chang
5 documents · 2019–2025
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in New Jersey.
The firmFujifilm Medical Systems U.S.A., Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.198(e)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Fujifilm Medical Systems U.S.A., 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 Fujifilm Medical Systems U.S.A., Inc.?
William R. Chang is named on this Form 483, for the inspection of Jun 12 – Jul 2, 2019. Each investigator has a profile showing what they cite most.
When was Fujifilm Medical Systems U.S.A., Inc. inspected by FDA?
The inspection ran Jun 12 – Jul 2, 2019, and the Form 483 is dated July 2, 2019.
How do I get the full Form 483 for Fujifilm Medical Systems U.S.A., 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.