Fujifilm Medical Systems U.S.A., Inc.
Form 483 issued April 9, 2015 · Wayne, New Jersey
- Inspection
- Mar 24 – Apr 9, 2015
- Investigator
- Li Li
- Observations
- 5
- Pages
- 6
- FEI number
- 2431293
In short: On April 9, 2015, FDA issued a Form 483 with 5 observations to Fujifilm Medical Systems U.S.A., Inc. in Wayne, New Jersey (FEI 2431293) after an inspection that ran Mar 24 – Apr 9, 2015. The investigator was Li Li. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
4 of 5 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
Complaints involving the possible failure of a device and labeling to meet any of its specifications…
- 02
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 03
Procedures for corrective and preventive action have…
- 04
A correction or removal, conducted to reduce a risk to health posed by a device, was…
This inspection in context
Li Li
4 documents · 2015–2018
Cites 820.100(a) (corrective and preventive action) 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(c)
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 5 observations on this Form 483, mostly about cAPA and production & process controls. 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.?
Li Li is named on this Form 483, for the inspection of Mar 24 – Apr 9, 2015. 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 Mar 24 – Apr 9, 2015, and the Form 483 is dated April 9, 2015.
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.