Terumo Cardiovascular Systems Corporation
Amended 483 issued July 11, 2015 · Ann Arbor, Michigan
- Observations
- 17
- Pages
- 18
- FEI number
- 1828100
In short: On July 11, 2015, FDA issued a Amended 483 with 17 observations to Terumo Cardiovascular Systems Corporation in Ann Arbor, Michigan (FEI 1828100). Most observations concern design controls and cAPA; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Observations span 4 systems, led by design controls.
Most cited: 21 CFR 820.30 (6×) · 820.50 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 0121 CFR 820
Procedures for conducting quality…
- 02
Procedures were not defined, documented, and completed for the identification, documentation, validation or verification, review, and…
- 03
Procedures for planning and conducting reviews of the design results at appropriate stages of the device's…
- 04
Procedures for validating the device…
13 more observations
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full amended 483This inspection in context
Questions about this amended 483
What did FDA find at Terumo Cardiovascular Systems Corporation?
FDA listed 17 observations on this Form 483, mostly about design controls, cAPA and records & documents. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
When was Terumo Cardiovascular Systems Corporation inspected by FDA?
This 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.