Terumo Cardiovascular Systems Corporation
Amended 483 issued July 11, 2015 · Ann Arbor, Indiana
- Inspection
- Mar 29, 2010
- Investigators
- Charles M. Spyr· Gary D. Urbiel Goldner· Kimberly Lewandowski-Walker
- Observations
- 15
- Pages
- 18
- FEI number
- 1828100
In short: On July 11, 2015, FDA issued a Amended 483 with 15 observations to Terumo Cardiovascular Systems Corporation in Ann Arbor, Indiana (FEI 1828100) after an inspection that ran Mar 29, 2010. The investigators were Charles M. Spyr, Gary D. Urbiel Goldner, Kimberly Lewandowski-Walker and Ryan J. Benedict. Most observations concern cAPA and management controls; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
10 of 15 observations on this amended 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
Management with executive responsibility has not ensured that an adequate and effective quality system has been…
- 02
Certain indicators of nonconformities are not investigated to determine the…
- 03
Not all of the actions needed to correct and prevent the recurrence of nonconforming product and…
- 04
Corrective and preventive actions have not been verified or validated to ensure that the action is…
11 more observations
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full amended 483This inspection in context
Charles M. Spyr
3 documents · 2009–2015
Cites 820.100(a)(1) (corrective and preventive action) 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 documentsOther sites cited under 820.20
See how FDA wrote the same problem up elsewhere.
Questions about this amended 483
What did FDA find at Terumo Cardiovascular Systems Corporation?
FDA listed 15 observations on this Form 483, mostly about cAPA, management controls and production & process controls. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected Terumo Cardiovascular Systems Corporation?
Charles M. Spyr, Gary D. Urbiel Goldner, Kimberly Lewandowski-Walker and Ryan J. Benedict are named on this Amended 483, for the inspection of Mar 29, 2010. Each investigator has a profile showing what they cite most.
When was Terumo Cardiovascular Systems Corporation inspected by FDA?
The inspection ran Mar 29, 2010, and the Amended 483 is dated July 11, 2015.
How do I get the full Amended 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.