Joseph R. Strelnik
FDA investigator
Appears on 13 documents from 2011 to 2022, mostly at sites in Indiana. Most often cites design controls (21 CFR 820.30).
- 13
- Documents on file
- 4.8
- Observations per 483
- 2011
- First seen
- 2022
- Most recent
What they cite most
From 63 observations- 21 CFR 820.30Design controls11
- 21 CFR 820.70Production and process controls8
- 21 CFR 820.75(a)Process validation6
- 21 CFR 820.100Corrective and preventive action5
- 21 CFR 820.90Nonconforming product5
- 21 CFR 820.198(a)Complaint files4
Activity by year
2011: 1, 2013: 1, 2015: 2, 2016: 4, 2017: 1, 2018: 1, 2019: 2, 2022: 1
Where
Indiana 11 · Missouri 1 · South Korea 1
Often inspects with
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Inspection history
13 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2022-02-24 | 483 Kimball Electronics Indianapolis, Inc.Feb 24, 2022 · Indianapolis, Indiana | Indianapolis, Indiana | 3 | |
| 2019-12-21 | 483 Meridian Medical Technologies, LLCDec 21, 2019 · St. Louis, Missouri | St. Louis, Missouri | 11 | |
| 2019-10-31 | 483 Biomedix WAIOct 31, 2019 · Bloomington, Indiana | Bloomington, Indiana | 11 | |
| 2018-02-01 | 483 Hanmi Pharm. Co., Ltd.Feb 1, 2018 · Pyeongtaek, South Korea | Pyeongtaek, South Korea | 1 | |
| 2017-10-16 | 483 Zimmer Biomet, Inc.Oct 16, 2017 · Warsaw, Indiana | Warsaw, Indiana | 8 | |
| 2016-11-22 | 483 Zimmer Biomet, Inc.Nov 22, 2016 · Warsaw, Indiana | Warsaw, Indiana | 4 | |
| 2016-08-15 | 483 Roche Diagnostics Operations, IncAug 15, 2016 · Indianapolis, Indiana | Indianapolis, Indiana | 1 |
About this profile
What does Joseph R. Strelnik inspect?
Joseph R. Strelnik appears on 13 documents on file covering 13 sites, mostly in Indiana.
What do they cite most often?
21 CFR 820.30 (design controls), followed by 21 CFR 820.70 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 Joseph R. Strelnik is dated Feb 24, 2022.