Susan M. Matthias
FDA investigator
Appears on 10 documents from 2013 to 2019, mostly at sites in Minnesota. Most often cites design controls (21 CFR 820.30(c)).
- 10
- Documents on file
- 2.7
- Observations per 483
- 2013
- First seen
- 2019
- Most recent
What they cite most
From 24 observations- 21 CFR 820.30(c)Design controls7
- 21 CFR 820.100Corrective and preventive action6
- 21 CFR 803.50(a)(1)If I am a manufacturer, what reporting requirements apply to me?2
- 21 CFR 820.75Process validation2
- 21 CFR 820.90(a)Nonconforming product2
- 21 CFR 1002.13Annual reports1
Activity by year
2013: 2, 2015: 1, 2016: 1, 2017: 3, 2018: 2, 2019: 1
Where
Minnesota 10
Often inspects with
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Inspection history
10 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2019-10-17 | 483 Medtronic NeurornodulationOct 17, 2019 · Minneapolis, Minnesota | Minneapolis, Minnesota | 2 | |
| 2018-12-04 | 483 Antares Pharma, Inc.Dec 4, 2018 · Minnetonka, Minnesota | Minnetonka, Minnesota | 1 | |
| 2018-06-22 | 483 Inspire Medical Systems Inc.Jun 22, 2018 · Maple Grove, Minnesota | Maple Grove, Minnesota | 1 | |
| 2017-12-18 | 483 Enteromedics, Inc.Dec 18, 2017 · Saint Paul, Minnesota | Saint Paul, Minnesota | 1 | |
| 2017-03-31 | 483 Spineology, IncMar 31, 2017 · Saint Paul, Minnesota | Saint Paul, Minnesota | 5 | |
| 2017-02-22 | 483 Lifecore Biomedical, LLCFeb 22, 2017 · Chaska, Minnesota | Chaska, Minnesota | 2 | |
| 2016-06-30 | 483 Monteris Medical CorpJun 30, 2016 · Plymouth, Minnesota | Plymouth, Minnesota | 5 |
About this profile
What does Susan M. Matthias inspect?
Susan M. Matthias appears on 10 documents on file covering 8 sites, mostly in Minnesota.
What do they cite most often?
21 CFR 820.30(c) (design controls), followed by 21 CFR 820.100 and 21 CFR 803.50(a)(1).
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 Susan M. Matthias is dated Oct 17, 2019.