FDA Intel

Terumo Cardiovascular Systems Corporation

Form 483 issued July 11, 2015 · Ann Arbor, Michigan

Inspection
May 10 – May 18, 2004
Observations
19
Pages
8
FEI number
1828100

In short: On July 11, 2015, FDA issued a Form 483 with 19 observations to Terumo Cardiovascular Systems Corporation in Ann Arbor, Michigan (FEI 1828100) after an inspection that ran May 10 – May 18, 2004. Most observations concern cAPA and management controls; the most-cited regulation is 21 CFR 820.30 (design controls).

At a glance

CAPA and management controls account for 10 of 13 observations.

CAPA6
Management controls4
Design controls3

Most cited: 21 CFR 820.30 (3×) · 820.100 (3×)

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

  1. 01
    21 CFR 820.20

    Management with executive responsibility has not ensured that an adequate and effective quality system has been…

  2. 02
    21 CFR 820.22

    Quality audits did not verify that the quality system is .effective in fulfilling…

  3. 03
    21 CFR 820.22

    Quality audits were not conducted at sufficient regular intervals, as prescribed by internal procedures to verifY…

  4. 04
    21 CFR 820.20

    Observation 4: scanned text, readable in the full document.

15 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The firm

Terumo Cardiovascular Systems Corporation history

All 6 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 820.30

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Terumo Cardiovascular Systems Corporation?

FDA listed 19 observations on this Form 483, mostly about cAPA, management controls and design controls. 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?

The inspection ran May 10 – May 18, 2004, and the Form 483 is dated July 11, 2015.

How do I get the full Form 483 for Terumo Cardiovascular Systems Corporation?

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