Sonya L. Karsik
FDA investigator
Appears on 9 documents from 2009 to 2019, mostly at sites in California. Most often cites design controls (21 CFR 820.30).
- 9
- Documents on file
- 12.3
- Observations per 483
- 2009
- First seen
- 2019
- Most recent
What they cite most
From 85 observations- 21 CFR 820.30Design controls11
- 21 CFR 606.160Records10
- 21 CFR 606.100Standard operating procedures8
- 21 CFR 211.113Control of microbiological contamination5
- 21 CFR 820.50Purchasing controls5
- 21 CFR 211.22Responsibilities of quality control unit4
Activity by year
2009: 2, 2010: 1, 2011: 1, 2012: 1, 2016: 1, 2017: 2, 2019: 1
Where
California 9
Often inspects with
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Inspection history
9 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2019-09-06 | 483 Diamond Wipes International, Inc.Sep 6, 2019 · Chino, California | Chino, California | 2 | |
| 2017-03-31 | 483 Amphastar Pharmaceuticals, IncMar 31, 2017 · Rancho Cucamonga, California | Rancho Cucamonga, California | 20 | |
| 2017-03-31 | 483 Amphastar Pharmaceuticals, Inc.Mar 31, 2017 · Rancho Cucamonga, California | Rancho Cucamonga, California | 20 | |
| 2016-03-24 | 483 Pacific Consolidated Industries LLCMar 24, 2016 · Riverside, California | Riverside, California | 2 | |
| 2012-09-11 | 483 Spinal Solutions, LLCSep 11, 2012 · Murrieta, California | Murrieta, California | 4 | |
| 2011-09-15 | 483 Spinal Solutions, LLCSep 15, 2011 · Murrieta, California | Murrieta, California | 16 | |
| 2010-09-24 | 483 American Red Cross Blood ServicesSep 24, 2010 · Pomona, California | Pomona, California | 22 |
About this profile
What does Sonya L. Karsik inspect?
Sonya L. Karsik appears on 9 documents on file covering 7 sites, mostly in California.
What do they cite most often?
21 CFR 820.30 (design controls), followed by 21 CFR 606.160 and 21 CFR 606.100.
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 Sonya L. Karsik is dated Sep 6, 2019.