Terumo Cardiovascular Systems Corporation
FDA inspection history across 2 sites, 2004 to 2015
- 5
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2004: one warning letter and one Form 483; 2005: one Form 483; 2015: two amended 483s and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2004–05Two Form 483s and one warning letter, at Ann Arbor, Michigan.
- 2015Two amended 483s and one Form 483, at Ann Arbor, Michigan and Ann Arbor, Indiana.
- 2015The longest 483 on file: 19 observations over 8 pages at Ann Arbor, Michigan.
Cited most
Across all Terumo Cardiovascular Systems observations on file
- 21 CFR 820.30Design controls10
- 21 CFR 820.100Corrective and preventive action9
- 21 CFR 820.198Complaint files6
- 21 CFR 820.20Management responsibility4
- 21 CFR 820.22Quality audit3
The complete Terumo Cardiovascular Systems file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Ann Arbor, Michigan
Three Form 483s, one amended 483 and one warning letter · 2004 to 2015 · 40 observations
Latest: Form 483, Jul 11, 2015 →Ann Arbor, Indiana
One amended 483 · 2015 · 15 observations
Latest: Form 483, Jul 11, 2015 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2015-07-11 | 483 Form 483 | Ann Arbor, Michigan | 19 | $99 |
| 2015-07-11 | Amended 483 Amended 483 | Ann Arbor, Michigan | 17 | $99 |
| 2015-07-11 | Amended 483 Amended 483 | Ann Arbor, Indiana | 15 | $99 |
| 2005-12-09 | 483 Form 483 | Ann Arbor, Michigan | 3 | $99 |
| 2004-08-31 | Warning letter Warning letter | Ann Arbor, Michigan | — | $99 |
| 2004-05-18 | 483 Form 483 | Ann Arbor, Michigan | 1 | $99 |
Investigators on these documents
Charles M. Spyr (1)Gary D. Urbiel Goldner (1)Kimberly Lewandowski-Walker (1)Kinh Quoc Mac (1)Ryan J. Benedict (1)William D. Timdey (1)
FEI number 1828100 · most recent document Jul 11, 2015
About Terumo Cardiovascular Systems Corporation
How many FDA Form 483s has Terumo Cardiovascular Systems Corporation received?
FDA Intel has 5 Form 483s on file for Terumo Cardiovascular Systems Corporation; the most recent is dated Jul 11, 2015.
When was Terumo Cardiovascular Systems Corporation last inspected by FDA?
The most recent FDA inspection document on file for Terumo Cardiovascular Systems Corporation is a Form 483 dated Jul 11, 2015, for the site in Ann Arbor, Michigan.
What did FDA cite at Terumo Cardiovascular Systems Corporation?
The regulations cited most in the observations on file for Terumo Cardiovascular Systems Corporation are 21 CFR 820.30 (Design controls), 10 times; 21 CFR 820.100 (Corrective and preventive action), 9 times; 21 CFR 820.198 (Complaint files), 6 times.
Has Terumo Cardiovascular Systems Corporation received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Terumo Cardiovascular Systems Corporation; the most recent is dated Aug 31, 2004.