Michael E. Maselli
FDA investigator
Appears on 6 documents from 2015 to 2023, most often at sites in Colorado. Most often cites control of microbiological contamination (21 CFR 211.113).
- 6
- Documents on file
- 6.0
- Observations per 483
- 2015
- First seen
- 2023
- Most recent
What they cite most
From 30 observations- 21 CFR 211.113Control of microbiological contamination5
- 21 CFR 211.100Written procedures; deviations3
- 21 CFR 211.165Testing and release for distribution3
- 21 CFR 211.160General requirements2
- 21 CFR 211.198Complaint files2
- 21 CFR 211.67Equipment cleaning and maintenance2
Activity by year
2015: 1, 2016: 3, 2023: 2
Where
Colorado 2 · Japan 2 · France 1 · Illinois 1
Often inspects with
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Inspection history
6 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2023-03-08 | 483 Rohto Pharmaceutical Co., Ltd.Mar 8, 2023 · Iga, Japan | Iga, Japan | 6 | |
| 2023-02-25 | 483 TOYOBO CO., LTD.Feb 25, 2023 · Otsu, Japan | Otsu, Japan | 5 | |
| 2016-09-12 | Response Pencol Compounding PharmacySep 12, 2016 · Denver, Colorado | Denver, Colorado | — | |
| 2016-09-01 | 483 Sage Products Inc 'Sep 1, 2016 · Cary, Illinois | Cary, Illinois | 6 | |
| 2016-08-08 | 483 Maplerose EntL-rprisej; LLC dba Pencol PhanuacyAug 8, 2016 · Denver, Colorado | Denver, Colorado | 10 | |
| 2015-06-09 | 483 Astrea MontsJun 9, 2015 · Monts, France | Monts, France | 3 |
About this profile
What does Michael E. Maselli inspect?
Michael E. Maselli appears on 6 documents on file covering 5 sites, most often in Colorado.
What do they cite most often?
21 CFR 211.113 (control of microbiological contamination), followed by 21 CFR 211.100 and 21 CFR 211.165.
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 Michael E. Maselli is dated Mar 8, 2023.