Dawn C. Olenjack
FDA investigator
Appears on 1 document from 2013, mostly at sites in Michigan. Most often cites written procedures; deviations (21 CFR 211.100).
- 1
- Documents on file
- 10.0
- Observations per 483
- 2013
- First seen
- 2013
- Most recent
What they cite most
From 10 observations- 21 CFR 211.100Written procedures; deviations4
- 21 CFR 211.165Testing and release for distribution2
- 21 CFR 211.188Batch production and control records2
- 21 CFR 211.25Personnel qualifications2
- 21 CFR 211.192Production record review1
Activity by year
2013: 1
Where
Michigan 1
Often inspects with
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Inspection history
1 document, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2013-10-09 | 483 Pharmacia and Upjohn Company, LLCOct 9, 2013 · Kalamazoo, Michigan | Kalamazoo, Michigan | 10 |
About this profile
What does Dawn C. Olenjack inspect?
Dawn C. Olenjack appears on 1 document on file covering 1 site, mostly in Michigan.
What do they cite most often?
21 CFR 211.100 (written procedures; deviations), followed by 21 CFR 211.165 and 21 CFR 211.188.
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 Dawn C. Olenjack is dated Oct 9, 2013.