Laureen M. Geniusz
FDA investigator
Appears on 10 documents from 2015 to 2026, mostly at sites in Ohio. Most often cites design controls (21 CFR 820.30).
- 10
- Documents on file
- 4.3
- Observations per 483
- 2015
- First seen
- 2026
- Most recent
What they cite most
From 43 observations- 21 CFR 820.30Design controls9
- 21 CFR 820.100(a)Corrective and preventive action8
- 21 CFR 820.75Process validation6
- 21 CFR 820.198(a)Complaint files5
- 21 CFR 820.50Purchasing controls4
- 21 CFR 820.90Nonconforming product4
Activity by year
2015: 2, 2016: 1, 2017: 3, 2018: 1, 2020: 1, 2023: 1, 2026: 1
Where
Ohio 10
Often inspects with
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Inspection history
10 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2026-02-27 | 483 Compass Health Brands Corp.Feb 27, 2026 · Brookpark, Ohio | Brookpark, Ohio | 1 | |
| 2023-06-27 | 483 Frantz Medical Development Ltd.Jun 27, 2023 · Mentor, Ohio | Mentor, Ohio | 5 | |
| 2020-10-07 | 483 Synapse Biomedical IncOct 7, 2020 · Oberlin, Ohio | Oberlin, Ohio | 4 | |
| 2018-09-24 | 483 Frantz Medical Development Ltd.Sep 24, 2018 · Mentor, Ohio | Mentor, Ohio | 5 | |
| 2017-08-18 | 483 Philips Medical Systems (Cleveland) IncAug 18, 2017 · Cleveland, Ohio | Cleveland, Ohio | 9 | |
| 2017-03-13 | 483 Marlen Manufacturing & Development Co.Mar 13, 2017 · Bedford, Ohio | Bedford, Ohio | 1 | |
| 2017-01-27 | 483 Zuga Medical Inc.Jan 27, 2017 · Beachwood, Ohio | Beachwood, Ohio | 1 |
About this profile
What does Laureen M. Geniusz inspect?
Laureen M. Geniusz appears on 10 documents on file covering 9 sites, mostly in Ohio.
What do they cite most often?
21 CFR 820.30 (design controls), followed by 21 CFR 820.100(a) and 21 CFR 820.75.
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 Laureen M. Geniusz is dated Feb 27, 2026.