Terumo Cardiovascular Systems Corporation
Form 483 issued May 18, 2004 · Ann Arbor, Michigan
- Inspection
- May 10 – May 18, 2004
- Investigator
- Kinh Quoc Mac
- Observations
- 1
- Pages
- 8
- FEI number
- 1828100
In short: On May 18, 2004, FDA issued a Form 483 with 1 observation to Terumo Cardiovascular Systems Corporation in Ann Arbor, Michigan (FEI 1828100) after an inspection that ran May 10 – May 18, 2004. The investigator was Kinh Quoc Mac. Most observations concern management controls; the most-cited regulation is 21 CFR 820.22 (quality audit).
At a glance
1 of 1 observations on this 483 concern management controls.
Most cited: 21 CFR 820.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Management with executive responsibility has not ensured that an adequate and effective quality system has been…
This inspection in context
Kinh Quoc Mac
1 document · 2004
Cites 820.22 (quality audit) 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 820.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Terumo Cardiovascular Systems Corporation?
FDA listed 1 observation on this Form 483, mostly about management controls. The most-cited regulation is 21 CFR 820.22 (quality audit). The opening words of each observation are shown on this page.
Who inspected Terumo Cardiovascular Systems Corporation?
Kinh Quoc Mac is named on this Form 483, for the inspection of May 10 – May 18, 2004. Each investigator has a profile showing what they cite most.
When was Terumo Cardiovascular Systems Corporation inspected by FDA?
The inspection ran May 10 – May 18, 2004, and the Form 483 is dated May 18, 2004.
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.