American Medical Systems Innovation
Form 483 issued April 3, 2015 · San Jose, California
- Inspection
- Mar 30 – Apr 3, 2015
- Investigator
- James D. Hildreth
- Observations
- 2
- Pages
- 3
- FEI number
- 2937094
In short: On April 3, 2015, FDA issued a Form 483 with 2 observations to American Medical Systems Innovation in San Jose, California (FEI 2937094) after an inspection that ran Mar 30 – Apr 3, 2015. The investigator was James D. Hildreth. Most observations concern design controls and cAPA; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Design controls and capa account for 2 of 2 observations.
Most cited: 21 CFR 820.30(g) (1×) · 803.56 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Design validation did not ensure the device conforms to defined user…
- 02
A supplemental report was not submitted to FDA within one month following receipt of information that…
This inspection in context
James D. Hildreth
6 documents · 2011–2016
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Oregon.
The firmAmerican Medical Systems Innovation history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(g)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at American Medical Systems Innovation?
FDA listed 2 observations on this Form 483, mostly about design controls and cAPA. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected American Medical Systems Innovation?
James D. Hildreth is named on this Form 483, for the inspection of Mar 30 – Apr 3, 2015. Each investigator has a profile showing what they cite most.
When was American Medical Systems Innovation inspected by FDA?
The inspection ran Mar 30 – Apr 3, 2015, and the Form 483 is dated April 3, 2015.
How do I get the full Form 483 for American Medical Systems Innovation?
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.