Terumo Cardiovascular Systems Corporation
Form 483 issued December 9, 2005 · Ann Arbor, Michigan
- Inspection
- Dec 6 – Dec 9, 2005
- Investigator
- William D. Timdey
- Observations
- 3
- Pages
- 2
- FEI number
- 1828100
In short: On December 9, 2005, FDA issued a Form 483 with 3 observations to Terumo Cardiovascular Systems Corporation in Ann Arbor, Michigan (FEI 1828100) after an inspection that ran Dec 6 – Dec 9, 2005. The investigator was William D. Timdey. Most observations concern cAPA and management controls.
At a glance
2 of 3 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
- 02
Complaints involving the possible failure of a device to meet any of its specifications were not…
- 03
Employees have not been…
This inspection in context
William D. Timdey
1 document · 2005
Cites 803.50 (if i am a manufacturer, what reporting requirements apply to me?) more than any other section. Most of their documents are for sites in Michigan.
The firmTerumo Cardiovascular Systems Corporation history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 803.50
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Terumo Cardiovascular Systems Corporation?
FDA listed 3 observations on this Form 483, mostly about cAPA and management controls. The opening words of each observation are shown on this page.
Who inspected Terumo Cardiovascular Systems Corporation?
William D. Timdey is named on this Form 483, for the inspection of Dec 6 – Dec 9, 2005. Each investigator has a profile showing what they cite most.
When was Terumo Cardiovascular Systems Corporation inspected by FDA?
The inspection ran Dec 6 – Dec 9, 2005, and the Form 483 is dated December 9, 2005.
How do I get the full Form 483 for Terumo Cardiovascular Systems Corporation?
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.