Gary D. Urbiel Goldner
FDA investigator
Appears on 4 documents from 2008 to 2015, mostly at sites in Indiana. Most often cites corrective and preventive action (21 CFR 820.100(a)).
- 4
- Documents on file
- 8.5
- Observations per 483
- 2008
- First seen
- 2015
- Most recent
What they cite most
From 34 observations- 21 CFR 820.100(a)Corrective and preventive action6
- 21 CFR 820.30(c)Design controls4
- 21 CFR 820.75(a)Process validation4
- 21 CFR 820.198Complaint files3
- 21 CFR 820.20Management responsibility3
- 21 CFR 820.90(a)Nonconforming product3
Activity by year
2008: 1, 2009: 1, 2011: 1, 2015: 1
Where
Indiana 2 · Michigan 2
Often inspects with
Charles M. Spyr· Eric S. Pittman· Kimberl Lewandowski-Walker
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Inspection history
4 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2015-07-11 | Amended 483 Terumo Cardiovascular Systems CorporationJul 11, 2015 · Ann Arbor, Indiana | Ann Arbor, Indiana | 15 | |
| 2011-07-22 | 483 Zimmer Inc.Jul 22, 2011 · Warsaw, Indiana | Warsaw, Indiana | 10 | |
| 2009-05-14 | 483 Stryker InstrumentsMay 14, 2009 · Kalamazoo, Michigan | Kalamazoo, Michigan | 8 | |
| 2008-12-10 | 483 Stryker Craniomaxillofacial DivisionDec 10, 2008 · Portage, Michigan | Portage, Michigan | 1 |
About this profile
What does Gary D. Urbiel Goldner inspect?
Gary D. Urbiel Goldner appears on 4 documents on file covering 4 sites, mostly in Indiana.
What do they cite most often?
21 CFR 820.100(a) (corrective and preventive action), followed by 21 CFR 820.30(c) and 21 CFR 820.75(a).
Can I read the observations?
Each document page previews the opening words of every observation. The full documents are available to buy, one at a time or together.
How current is this profile?
The most recent document on file for Gary D. Urbiel Goldner is dated Jul 11, 2015.