Brett R. Havranek
FDA investigator
Appears on 6 documents from 2015 to 2018, mostly at sites in Kansas. Most often cites production record review (21 CFR 211.192).
- 6
- Documents on file
- 6.7
- Observations per 483
- 2015
- First seen
- 2018
- Most recent
What they cite most
From 40 observations- 21 CFR 211.192Production record review5
- 21 CFR 211.68Automatic, mechanical, and electronic equipment5
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.110Sampling and testing of in-process materials and drug products2
- 21 CFR 211.165(a)Testing and release for distribution2
Activity by year
2015: 1, 2016: 2, 2017: 1, 2018: 2
Where
Kansas 4 · Canada 2
Often inspects with
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Inspection history
6 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2018-06-01 | 483 Jubilant HollisterStier General PartnershipJun 1, 2018 · Kirkland, Canada | Kirkland, Canada | 2 | |
| 2018-04-27 | 483 Groupe PARIMA Inc.Apr 27, 2018 · Montreal, Canada | Montreal, Canada | 3 | |
| 2017-04-14 | 483 Cramer Products IncApr 14, 2017 · Gardner, Kansas | Gardner, Kansas | 13 | |
| 2016-09-21 | 483 Fagron Compounding Services LLC dba Fagron Sterile ServicesSep 21, 2016 · Wichita, Kansas | Wichita, Kansas | 4 | |
| 2016-06-08 | 483 Hospira Inc. A Pfizer CompanyJun 8, 2016 · McPherson, Kansas | McPherson, Kansas | 14 | |
| 2015-12-03 | 483 JCB Laboratories LLCDec 3, 2015 · Wichita, Kansas | Wichita, Kansas | 4 |
About this profile
What does Brett R. Havranek inspect?
Brett R. Havranek appears on 6 documents on file covering 6 sites, mostly in Kansas.
What do they cite most often?
21 CFR 211.192 (production record review), followed by 21 CFR 211.68 and 21 CFR 211.113.
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 Brett R. Havranek is dated Jun 1, 2018.